MT-3724NHL001: Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL

• Sponsor: Molecular Templates, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02361346
• Collaborator: (none)
• Enrollment: 38
• Locations: 41
• Arms: 9
• Actual Duration (Months): 73.6
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of MT-3724 in subjects with relapsed or refractory B-Cell NHL or relapsed and refractory CLL (Part 1 only) and relapsed and refractory DLBCL (Part 2 and Part 3). Part 3 evaluates the efficacy of MT-3724.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's B-cell Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Small Lymphocytic Leukemia; Diffuse Large B Cell Lymphoma; Blood Cancer; Hematological Malignancy	Drug: MT-3724 Phase 1; Drug: MT-3724 Phase 2	Phase 1/Phase 2

Detailed Description

This is a three-part Phase 2 study

Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 [Completed]

Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 in the MTD Expansion Cohort.

Part 3: (Phase 2 MTD Expansion Cohort) Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC.

It is anticipated that up to 100 patients will be enrolled in Part 3. Treatment will continue for up to six 21 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 6 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Mar 22, 2021
• Actual Study Completion Date: Mar 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) Part 1: MT-3724 5 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Experimental: Part 1: Cohort 2- 10 mcg/kg/Dose Part 1: MT-3724 10 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part) until recommended phase 2 dose of MT-3724 is determined	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Experimental: Part 1: Cohort 3- 20 mcg/kg/Dose Part 1: MT-3724 20 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Experimental: Part 1: Cohort 4- 50 mcg/kg/Dose Part 1: MT-3724 50 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Part 1) until recommended phase 2 dose of MT-3724 is determined	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Experimental: Part 1: Cohort 5- 100 mcg/kg/Dose Part 1: MT-3724 100 mcg/kg/dose IV for 6 doses over 12 days, followed by dose escalations (Phase 1) until recommended phase 2 dose of MT-3724 is determined	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Experimental: Part 1: Cohort 6- 75 mcg/kg/Dose Part 1b: MT-3724 75 mcg/kg/dose IV for 6 doses over 12 days of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724 (subject will continue with dose that was tolerated in the Part 1 portion of the study)	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
Experimental: Part 2: Cohort 7- MTD Expansion Cohort Part 2: MT-3724 IV for 6 doses administered within 14 days of 21-Day cycle up to 6 Cycles. If the Subject exhibits stable disease or PR after end of Cycle 6 and investigator determines ratio is favorable, treatment with MT- 3724 may be continued for up to additional 6 cycles.	Drug: MT-3724 Phase 1; Intravenous dosing Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.; Drug: MT-3724 Phase 2; Intravenous dosing on Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles.
Experimental: Part 3: All MT-3724 Treated Participants Part 3: MT-3724 IV 50 µg/kg/dose administered on Days 1, 3, 5, 8, 10, and 12 of each 21-day cycle. Treatment will continue until death, disease progression, unacceptable toxicity, withdrawal of consent, or another reason for withdrawal, or until study discontinuation	Drug: MT-3724 Phase 2; Intravenous dosing on Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles.
Experimental: Part 4: All MT-3724 Treated Participants Part 4: In this arm, subjects were planned to receive all doses of MT-3724 as IV infusion as confirmed in Part 3.	Drug: MT-3724 Phase 2; Intravenous dosing on Days 1, 3, 5, 8, 10 and 12; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles.

Outcome Measures

Primary Outcome Measures

1. Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 [Days 1, 3, 5, 8, 10 and 12]

   The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

2. Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 [Part 1 and 2 : Days 1, 3 and 12]

   Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.

3. Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724 [Part 1 and 2: Days 1, 3 and 12]

   Blood samples were collected at indicated timepoints for the determination of tmax.

4. Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 [Part 1 and 2: Days 1, 3 and 12]

   Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.

5. Part 1 and 2: Half Life (t1/2) of MT-3724 [Part 1 and 2: Days 1, 3 and 12]

   Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.

6. Part 1 and 2: Volume of Distribution (Vz) of MT-3724 [Part 1 and 2: Days 1, 3 and 12]

   Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.

7. Part 1 and 2: Clearance (CL) of MT-3724 [Part 1 and 2: Days 1, 3 and 12]

   Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.

8. Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes [Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)]

   CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus

9. Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed [Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)]

   Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.

10. Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs [Up to Day 45]

    An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.

11. Part 3: Number of Participants With Clinically Significant Laboratory Parameters [Up to Day 45]

    Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.

12. Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values [Up to Day 26]

    Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.

13. Part 3: Number Participants With Clinically Significant Vital Signs [Up to Day 45]

    Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.

14. Part 3: Number of Participants With Clinically Significant Physical Findings [Up to Day 26]

    Physical examination was performed by a physician or a qualified delegate at the investigating site.

15. Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.

Secondary Outcome Measures

1. Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs [Up to Day 45]

   An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.

2. Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma [Up to Day 45]

   Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board.

3. Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.

4. Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression.

5. Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   DCR defined as percentage of participants who have achieved CR, PR and stable disease.

6. Part 3: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.

7. Part 3: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   Blood samples were planned to be collected at indicated timepoints for the analysis of tmax of MT-3724 monotherapy.

8. Part 3: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.

9. Part 3: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

   Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.

10. Part 3: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.

11. Part 3: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy

12. Part 3: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL [Up to Day 45]

    Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.

13. Part 3: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL [Up to Day 45]

    Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.

14. Part 3: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL [Up to Day 45]

    Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.

15. Part 3: Number of Participants With ADA When Treated With MT-3724 [Up to Day 45]

    Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.

16. Part 4: DOR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Duration of response was defined as the time from the first occurrence of either complete or partial response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were planned to be censored at time of last disease assessment. Only responders (CR or PR) were planned to be included for this analysis.

17. Part 4: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs [Up to Day 45]

    An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.

18. Part 4: Number of Participants With SAEs [Up to Day 45]

    A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function.

19. Part 4: Number of Participants With Clinically Significant Laboratory Parameters [Up to Day 45]

    Blood samples were planned to be collected for the analysis of laboratory parameters.

20. Part 4: Number Participants With Clinically Significant Vital Signs [Up to Day 45]

    Vital signs parameters including systolic and diastolic blood pressure, heart rate, respiration rate, body temperature and body weight were planned to be analyzed.

21. Part 4: Number of Participants With Clinically Significant ECG Values [Up to Day 26]

    Standard resting 12-lead ECG assessments was planned to be performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.

22. Part 4: Number of Participants With Adverse Events Suggestive of Cardiotoxicity [Up to Day 26]

    Number of participants with any adverse events leading to cardiotoxicity when treated with MT-3724 was planned to be analyzed.

23. Part 4: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Overall response rate was defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.

24. Part 4: DCR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    DCR was defined as percentage of participants who has achieved CR, PR and stable disease.

25. Part 4: Progression-free Survival (PFS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Progression-free survival was defined as the time from study enrollment to the earliest date of disease progression or death from any cause.

26. Part 4: Overall Survival (OS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Overall survival was defined as the time from study enrollment to death from any cause.

27. Part 4: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.

28. Part 4: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of Tmax of MT-3724 monotherapy.

29. Part 4: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.

30. Part 4: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.

31. Part 4: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.

32. Part 4: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL [Up to Day 45]

    Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy.

33. Part 4: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL [Up to Day 45]

    Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.

34. Part 4: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL [Up to Day 45]

    Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.

35. Part 4: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL [Up to Day 45]

    Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.

36. Part 4: Number of Participants With ADA When Treated With MT-3724 [Up to Day 45]

    Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants must be informed about the study and fully consent to participation as demonstrated by signing the written ICF before any screening procedure.

• Male and female participants >= 18 years of age at the time of informed consent.

• Participants must have relapsed or refractory Diffuse large B cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization classification. Participants must have proof of cluster of differentiation 20 plus (CD20+) DLBCL, based on either:

• 1. historical biopsies (obtained with diagnosis of relapsed or refractory disease), or
• 1. fresh biopsies
• 1. bone marrow biopsy, excisional lymph node biopsy, and core biopsy of any involved organ are all acceptable methods; Fine Needle Aspirate is not acceptable.

• Participants must have received at least 2 standard of care (SoC) regimens (including anti-CD20 antibody therapy) appropriate for DLBCL treatment.

• 1. Participants whose prior therapy includes chimeric antigen receptor T-cell (CAR-T-cell) therapy are eligible.
• 1. Participants who underwent stem cell transplant (SCT) > 100 days for autologous SCT or > 180 days for allogeneic SCT before study drug administration.
• 1. Participants who have been ineligible for SoC DLBCL treatments may be eligible at the investigator's discretion, upon sponsor approval.

• Participants must have at least 1 bi-dimensional tumor lesion at screening that is measurable by computerized tomography (CT) and/or magnetic resonance imaging (MRI) according to the Lugano criteria. Bi-dimensionally measurable tumor lesion by CT and/or MRI is defined as longest diameter of > 1.5 centimeters (cm) for lymph nodes and > 1.0 cm for extranodal disease.

• Participants must have life expectancy of > 3 months from the start of treatment.

• Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• Participants must have met ALL the following laboratory criteria:

• 1. absolute neutrophil count (ANC) >= 1.0 × 10^9 cells per liter with no myeloid growth factors (granulocyte colony-stimulating factor [G-CSF] or granulocyte-macrophage colony-stimulating factor preparations) administered within 2 weeks of Cycle 1 Day 1.
• 1. platelet count >= 50 × 10^9 cells per liter with no Thrombopoietin-receptor agonists agents or platelet transfusions given within 2 weeks of Cycle 1 Day 1.
• 1. hemoglobin >= 8.0 grams per deciliter (g/dL) with no erythropoietin stimulating agents or peripheral red blood cell (PRBC) transfusions within 2 weeks of Cycle 1 Day 1
• 1. creatinine clearance (CLcr) to be >= 50 milliliter per minute (ml/min) either measured or estimated using the Cockcroft-Gault formula.
• 1. total bilirubin (or direct bilirubin for patients with Gilbert's disease < 1.5 × upper limit of normal (ULN)
• 1. alanine transaminase (ALT) ≤ 3.0 × ULN (or <= 5.0 x ULN if liver involvement).
• 1. aspartate aminotransferase (AST) <= 3.0 × ULN (or <= 5.0 x ULN if liver involvement).
• 1. international normalized ratio (INR) or prothrombin time (PT) <= 1.5 x ULN (unless on therapeutic anticoagulants).
• 1. Activated partial thromboplastin time <= 1.5 x ULN (unless on therapeutic anticoagulants).

• Have adequate serum albumin, as determined by: a. albumin >= 3.0 g/dL.

• QT interval correction for heart rate using Fridericia's formula (QTcF) <= 480 milliseconds determined as the average of 3 QTcF values from the triplicate electrocardiogram (ECG) obtained at screening.

• Women of reproductive potential must have a negative highly sensitive pregnancy test within 72 hours before the start of treatment. Women who are postmenopausal or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy) may be considered as not of reproductive potential.

• Participants of reproductive potential must agree either to abstain continuously from heterosexual intercourse or to use a highly effective birth control method from signing the informed consent until the short term follow-up (STFU) visit for females and until 90 days after the last dose of MT-3724 for males.

• Participants must be able to comply with all study-related procedures and medication use.

Exclusion Criteria

Prior or Current Therapies

• Received any amount of anti-CD20 monoclonal antibodies (mAbs) within the following periods before the start of treatment:

• 1. Rituximab (Rituxan®/MabThera® or rituximab biosimilar): within 84 days (12 weeks); if a participant has received rituximab within 37 weeks before the start of treatment, then serum rituximab level must be negative (< 500 nanograms per milliliter [ng/mL]) at screening.
• 1. Obinutuzumab (Gazyva®/Gazyvaro®): 184 days c. Ofatumumab (Arzerra®): 88 days

1. Any other anti-CD20 agents (eg, investigational agents), the washout period is 5 half-lives. The investigator must contact the medical monitor to discuss the most Compound: MT-3724 appropriate washout for non-approved CD20-targeting agents, where the half-life (t1/2) is not known.

• Received approved or investigational treatment for DLBCL within 4 weeks before the start of treatment. For small molecules (MW < 0.9 kilodaltons [kDa]), the washout is 5 half-lives or at least 2 weeks. Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.

• Received radiation therapy to tumor lesions that would serve as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between radiation therapy and screening according to the Lugano Classification

o a. Palliative radiation therapy to non-target lesions may be permitted at the investigator's discretion after consultation with the medical monitor and sponsor.

• Require the use of systemic immune modulators during study treatment:

• 1. Systemic immune modulators include, but are not limited to, systemic corticosteroids at doses > 20 milligrams per day (mg/day) of prednisone equivalent, cyclosporine and tacrolimus.
• 1. The use of non-steroidal anti-inflammatory drugs (NSAIDS) is permitted.

• Received any live vaccines within 4 weeks before the start of treatment.

• Prior treatment with MT-3724.

Medical History

• Current evidence of Common Terminology Criteria for Adverse Events (CTCAE) Grade > 1 toxicity (due to prior anticancer therapy) before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria.

• Current evidence of significant (CTCAE Grade ≥ 2) infection or wound within 4 weeks before the start of treatment. a. Participants with Grade 2 infection that has stabilized or improved with oral anti-infectives before the start of treatment may be eligible at the sponsor's discretion.

• Known or suspected hypersensitivity to the study drug or excipients contained in the study drug formulation.

• Current evidence of hypersensitivity or other underlying illness requiring systemic corticosteroids at doses > 20 mg/day prednisone equivalent.

• Current evidence of uncontrolled human immunodeficiency syndrome (HIV), hepatitis B virus (HBV) or /hepatitis C virus (HCV) at screening. Serology testing is not required if seronegativity is documented in the medical history, and if there are no clinical signs suggestive of HIV or hepatitis infections, or suspected exposure. The following exceptions apply for participants with positive viral serology:

• 1. Participants with HIV and an undetectable viral load and CD4+ T-cell (CD4+) counts >= 350 cells per milliliter may be enrolled, but must be taking appropriate opportunistic infection prophylaxis, if clinically relevant.
• 1. Participants with positive HBV serology are eligible if they have an undetectable viral load and the participant will receive antiviral prophylaxis for potential HBV reactivation per institutional guidelines.
• 1. Participants with positive HCV serology are eligible if quantitative polymerase chain reaction (PCR) for plasma HCV ribonucleic acid (RNA) is below the lower limit of detection. Concurrent antiviral HCV treatment per institutional guidelines is allowed.

• Current evidence of incomplete recovery from surgery or radiotherapy before start of treatment, or planned surgery or radiotherapy from the start of treatment until the end of treatment (EoT) visit, except minor elective surgery deemed acceptable by the investigator or palliative radiation therapy to non-target lesions.

• History of cardiovascular, renal, hepatic or any other disease within 3 months before the start of treatment that in the investigator's opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results.

• History or current evidence of neoplastic disease that is histologically distinct from NHL, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer. Participants with prior, curatively treated cancer > 2 years ago before the start of treatment can be enrolled.

• Current evidence of new or growing brain or spinal metastases during screening.

Participants with known brain or spinal metastases may be eligible if they:

• 1. Had radiotherapy or another appropriate therapy for the brain or spinal metastases; concurrent prophylactic treatment is allowed
• 1. Neurologic symptoms must be stable and no worse than Grade 2
• 1. Have evidence of stable brain or spinal disease on CT or MRI scan obtained within 4 weeks before signing the informed consent and compared with prior imaging results
• 1. Do not require steroid therapy (or, if applicable, have been stable on dose of no more than prednisone 20 mg/day or equivalent by C1D1)

• Women who are pregnant or breastfeeding.

• History of non-adherence to the schedule of procedures or medication use. 18. Current evidence of Graft vs Host Disease

• History or current evidence of significant cardiovascular disease including, but not limited to, the following conditions:

• 1. Unstable angina (symptoms of angina at rest) or new-onset angina within 3 months before the start of treatment.
• 1. Arterial thrombosis or pulmonary embolism within 3 months before the start of treatment.
• 1. Myocardial infarction or stroke within 3 months before the start of treatment.
• 1. Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade >= 2), non-malignant pleural effusion (CTCAE Grade ≥ 2) or malignant pleural effusion (CTCAE Grade >= 3) within 3 months before the start of treatment with MT-3724.
• 1. Congestive heart failure (New York Heart Association [NYHA] Class III or IV) at screening or left ventricular ejection fraction (LVEF) <= 45 percent (%), assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 1 month before starting study treatment (inclusion of participants with LVEF between 40% to 45% should be discussed with the medical monitor and approved by the sponsor). (ECHO or MUGA performed within 6 months before screening and at least 28 days after the last cancer therapy is acceptable provided the participant has not received any potentially cardiotoxic agents since then).
• 1. Cardiac arrhythmia requiring anti-arrhythmic therapy at screening. Participants receiving digoxin, calcium channel blockers, or beta-adrenergic blockers are eligible at the investigator's discretion after consultation with medical monitor and sponsor if the dose has been stable for >= 2 weeks before the start of treatment with MT-3724. Participants with sinus arrhythmia and infrequent premature ventricular contractions are eligible at the investigator's discretion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona	Tucson	Arizona	United States	85724
2	Innovative Clinical Research Institute, LLC	Whittier	California	United States	90602
3	21st Century Oncology - Jacksonville	Jacksonville	Florida	United States	32204
4	Orlando Health, Inc.	Orlando	Florida	United States	32806
5	Orlando Health, Inc.	Orlando	Florida	United States
6	BRCR Medical Center	Plantation	Florida	United States	33322
7	ASCLEPES Research Centers	Weeki Wachee	Florida	United States	34607
8	Columbus Regional Research Institute	Columbus	Georgia	United States	31904
9	University of Illinois, Cancer Center	Chicago	Illinois	United States	60612
10	Healthcare Research Network III, LLC	Tinley Park	Illinois	United States
11	Carle Foundation Hospital	Urbana	Illinois	United States
12	Norton Healthcare, Inc	Louisville	Kentucky	United States
13	New York University Langone Medical Center	New York	New York	United States	10016
14	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065
15	University of North Carolina	Chapel Hill	North Carolina	United States	27599
16	MD Anderson Cancer Center	Houston	Texas	United States	77030
17	UT Health San Antonio Cancer	San Antonio	Texas	United States	78229
18	Grodno University Hospital	Grodno		Belarus
19	Minsk City Clinical Oncology Center	Minsk		Belarus	220013
20	Cross Cancer Institute	Edmonton	Alberta	Canada
21	Cancer Centre of Southeastern Ontario at Kingston General Hospital	Kingston	Ontario	Canada	K7L 2V7
22	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9
23	Montreal Oncology Research	Quebec		Canada	H1M 1B1
24	LLC ARENSIA Exploratory Medicine	Tbilisi		Georgia	0112
25	Rabin Medical Center, Davidoff Cancer Center, Hemato-Oncology Institute	Petah-Tikva		Israel	49100
26	Chaim Sheba Medical Center, Department of Hematology	Ramat Gan		Israel
27	The Tel Aviv Sourasky Medical Center, Department of Hematology and Bone Marrow Transplantation	Tel-Aviv		Israel
28	ARENSIA Exploratory Medicine,	Chisinau		Moldova, Republic of	MD-2025
29	Maria Sklodowska-Curie National Institute of Oncology - National Research Institute	Gliwice		Poland
30	University Hospital in Krakow, Teaching Unit of the Hematology Department	Kraków		Poland
31	Frederic Chopin Provincial Teaching Hospital, Teaching Department of Hematology	Rzeszów		Poland	35-055
32	Our Doctor Clinical Trials Center	Torun		Poland
33	Institute of Hematology and Transfusion Medicine, Department of Hematology	Warsaw		Poland
34	Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation	Wroclaw		Poland	50-367
35	Clinical Center Kragujevac, Clinic of Hematology	Kragujevac		Serbia
36	Clinical Center of Vojvodina, Clinic of Hematology	Novi Sad		Serbia
37	Catalan Institute of Oncology (ICO) - Hospital Duran i Reynals, Department of Clinical Hematology	Barcelona		Spain
38	University Hospital Vall d'Hebron (HUVH), Department of Hematology	Barcelona		Spain
39	Hospital Universitario QuironSalud Madrid	Madrid		Spain	28223
40	University Hospital Virgen del Rocio (HUVR), Department of Hematology	Seville		Spain
41	Medical Center of Limited Liability Company "Medical Centre Named by Academician Yurii Spizhenko	Kyiv		Ukraine	08112

Sponsors and Collaborators

• Molecular Templates, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Feb 12, 2021
• Statistical Analysis Plan - Aug 15, 2018

More Information

Publications

None provided.

• Responsible Party: Molecular Templates, Inc.
• ClinicalTrials.gov Identifier: NCT02361346
• Other Study ID Numbers: MT-3724_NHL_001
• First Posted: Feb 11, 2015
• Last Update Posted: Aug 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Molecular Templates, Inc.: CD20; immunotoxin; NHL; non-Hodgkin's lymphoma; lymphoma; cancer; antibodies; immunotherapy; safety; pharmacokinetics; maximum tolerated dose; MT-3724; relapsed; refractory; leukemia; CLL; SLL; DLBCL; efficacy
• Additional relevant MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Hematologic Neoplasms; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

Participant Flow

Recruitment Details	This 4-part study evaluated safety, pharmacodynamics and efficacy of MT-3724 in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Part 1 was multiple ascending dose study and Parts 2, 3 and 4 were multi-center, multinational, open-label, single-arm evaluation of MT-3724 administered as monotherapy in repeat doses.
Pre-assignment Detail	A total of 27 participants were enrolled in Parts 1 and 2 and 11 participants in Part 3. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. The study was terminated as no participants in Part 3 showed a response and the potential risks outweighed potential benefit.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)	Part 3	Part 4
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort either received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	MT-3724 was administered at a dose of 50μg/kg/dose via IV infusion for all participants	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle.
Period Title: Part 1 and 2 ( Up to Day 112)
STARTED	3	3	3	4	2	6	6	0	0
COMPLETED	3	3	3	3	0	6	6	0	0
NOT COMPLETED	0	0	0	1	2	0	0	0	0
Period Title: Part 1 and 2 ( Up to Day 112)
STARTED	0	0	0	0	0	0	0	11	0
COMPLETED	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	11	0
Period Title: Part 1 and 2 ( Up to Day 112)
STARTED	0	0	0	0	0	0	0	0	0
COMPLETED	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)	Part 3: All MT-3724 Treated Participants	Part 4: All MT-3724 Treated Participants	Total
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle	Total of all reporting groups
Overall Participants	3	3	3	4	2	6	6	11	0	38
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	73.3 (6.43)	70.7 (8.74)	64.3 (14.01)	57.8 (16.66)	65.0 (4.24)	67.2 (4.40)	59.3 (10.58)	57.5 (14.77)	64.4 (5.90)
Sex: Female, Male (Count of Participants)
Female	0 0%	2 66.7%	2 66.7%	3 75%	1 50%	4 66.7%	5 83.3%	3 27.3%	20 Infinity
Male	3 100%	1 33.3%	1 33.3%	1 25%	1 50%	2 33.3%	1 16.7%	8 72.7%	18 Infinity
Race/Ethnicity, Customized (Count of Participants)
White	2 66.7%	3 100%	3 100%	2 50%	2 100%	5 83.3%	6 100%	11 100%	34 Infinity
Asian	1 33.3%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	2 Infinity
Other	0 0%	0 0%	0 0%	2 50%	0 0%	0 0%	0 0%	0 0%	2 Infinity

Outcome Measures

1. Primary Outcome

Title	Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724
Description	The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Time Frame	Days 1, 3, 5, 8, 10 and 12

Outcome Measure Data

Analysis Population Description

Safety Set comprises of all participants who received any amount of MT-3724

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Measure Participants	3	3	3	4	2	6
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%	2 100%	0 0%

2. Primary Outcome

Title	Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274
Description	Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274.
Time Frame	Part 1 and 2 : Days 1, 3 and 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set (PAS). All subjects from the Safety Set with sufficient serum concentration data to determine the primary PK parameters. Only those participants with data available at specified timepoints were analyzed. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Measure Participants	1	3	3	7	9	2	6
Geometric Mean (Geometric Coefficient of Variation) [Nanograms per milliliter]	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)

3. Primary Outcome

Title	Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724
Description	Blood samples were collected at indicated timepoints for the determination of tmax.
Time Frame	Part 1 and 2: Days 1, 3 and 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724
Measure Participants	3	3	3	4	2	6	6
Median (Full Range) [Hours]	NA	NA	NA	NA	NA	NA	NA

4. Primary Outcome

Title	Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724
Description	Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast.
Time Frame	Part 1 and 2: Days 1, 3 and 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2 - 10mcg/kg/Dose	Part 1: Cohort 3 - 20mcg/kg/Dose	Part 1: Cohort 4 - 50mcg/kg/Dose	Part 1: Cohort 5 - 100mcg/kg/Dose	Part 1: Cohort 6 - 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724
Measure Participants	3	3	3	4	2	6	6
AUC (0-4)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)
AUC (0-infinity)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)
AUClast	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)

5. Primary Outcome

Title	Part 1 and 2: Half Life (t1/2) of MT-3724
Description	Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724.
Time Frame	Part 1 and 2: Days 1, 3 and 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Part 2 was analyzed as a single-arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day	Part 1: Cohort 2: 10 mcg/kg/Dose/Day	Part 1: Cohort 3: 20 mcg/kg/Dose/Day	Part 1: Cohort 4: 50 mcg/kg/Dose/Day	Part 1: Cohort 5: 100 mcg/kg/Dose/Day	Part 1: Cohort 6: 75 mcg/kg/Dose/Day	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 of 21-Day cycle for up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Measure Participants	3	3	3	4	2	6	6
Geometric Mean (Geometric Coefficient of Variation) [Hour]	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)

6. Primary Outcome

Title	Part 1 and 2: Volume of Distribution (Vz) of MT-3724
Description	Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724.
Time Frame	Part 1 and 2: Days 1, 3 and 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day	Part 1: Cohort 2: 10 mcg/kg/Dose/Day	Part 1: Cohort 3: 20 mcg/kg/Dose/Day	Part 1: Cohort 4: 50 mcg/kg/Dose/Day	Part 1: Cohort 5: 100 mcg/kg/Dose/Day	Part 1: Cohort 6: 75 mcg/kg/Dose/Day	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Measure Participants	3	3	3	4	2	6	6
Geometric Mean (Geometric Coefficient of Variation) [Liters]	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)

7. Primary Outcome

Title	Part 1 and 2: Clearance (CL) of MT-3724
Description	Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724.
Time Frame	Part 1 and 2: Days 1, 3 and 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day	Part 1: Cohort 2: 10 mcg/kg/Dose/Day	Part 1: Cohort 3: 20 mcg/kg/Dose/Day	Part 1: Cohort 4: 50 mcg/kg/Dose/Day	Part 1: Cohort 5: 100 mcg/kg/Dose/Day	Part 1: Cohort 6: 75 mcg/kg/Dose/Day	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.
Measure Participants	3	3	3	4	2	6	6
Geometric Mean (Geometric Coefficient of Variation) [Liters per hour]	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)	NA (NA)

8. Primary Outcome

Title	Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes
Description	CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus
Time Frame	Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Measure Participants	3	3	3	4	0	6	0
Cycle 1 Day 8	114 (NA)	325 (NA)	244 (NA)	57.7 (91.166)	126 (NA)
Cycle 1 Day 23	143 (NA)	104 (NA)	131 (NA)	67.0 (NA)
Cycle 3 Day 1	67.0 (NA)	134 (NA)	60.0 (NA)	1170 (1965.6)	34.0 (NA)
Cycle 5 Day 1	132 (NA)	180 (NA)	53.0 (NA)	26.0 (31.1127)	39.0 (NA)
Day 120 (End of study)	79.0 (NA)	184 (NA)	49.0 (NA)	22.87 (18.17)	44.0 (NA)

9. Primary Outcome

Title	Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed
Description	Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented.
Time Frame	Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study)

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Measure Participants	3	3	3	4	2	6	0
Cycle 1 Day 23	0 0%	3 100%	1 33.3%	1 25%	0 0%	1 16.7%
Cycle 2 Day 1	0 0%	3 100%	1 33.3%	4 100%	0 0%	2 33.3%
Cycle 3 Day 1	0 0%	2 66.7%	1 33.3%	2 50%	0 0%	1 16.7%
Cycle 4 Day 1	1 33.3%	2 66.7%	1 33.3%	2 50%	0 0%	1 16.7%
Cycle 5 Day 1	1 33.3%	2 66.7%	1 33.3%	1 25%	0 0%	1 16.7%
Day 120 (end of study)	2 66.7%	2 66.7%	1 33.3%	4 100%	0 0%	3 50%

10. Primary Outcome

Title	Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
Description	An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set.

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	11
Serious TEAEs	3 100%
Non-serious TEAEs	11 366.7%

11. Primary Outcome

Title	Part 3: Number of Participants With Clinically Significant Laboratory Parameters
Description	Blood samples were collected at indicated timepoints for the analysis of laboratory parameters.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set.

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	11
Count of Participants [Participants]	0 0%

12. Primary Outcome

Title	Part 3: Number of Participants With Clinically Significant Electrocardiogram (ECG) Values
Description	Standard resting 12-lead ECG assessments was performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Time Frame	Up to Day 26

Outcome Measure Data

Analysis Population Description

Safety Set.

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	11
Count of Participants [Participants]	0 0%

13. Primary Outcome

Title	Part 3: Number Participants With Clinically Significant Vital Signs
Description	Vital signs including systolic and diastolic blood pressure, respiratory rate, heart rate and body temperature were assessed at indicated time points.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set.

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	11
Count of Participants [Participants]	0 0%

14. Primary Outcome

Title	Part 3: Number of Participants With Clinically Significant Physical Findings
Description	Physical examination was performed by a physician or a qualified delegate at the investigating site.
Time Frame	Up to Day 26

Outcome Measure Data

Analysis Population Description

Safety Set.

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	11
Count of Participants [Participants]	2 66.7%

15. Primary Outcome

Title	Part 4: Overall Response Rate (ORR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by independent, blinded central review.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

16. Secondary Outcome

Title	Part 1 and 2: Number of Participants Reporting Worst Case Serious Treatment Emergent Adverse Events (TEAEs) and Non-serious TEAEs
Description	An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set comprises of all participants who received any amount of MT-3724. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.

Arm/Group Title	Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose)	Part 1: Cohort 2- 10 mcg/kg/Dose	Part 1: Cohort 3- 20 mcg/kg/Dose	Part 1: Cohort 4- 50 mcg/kg/Dose	Part 1: Cohort 5- 100 mcg/kg/Dose	Part 1: Cohort 6- 75 mcg/kg/Dose	Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.	Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.
Measure Participants	3	3	3	4	2	6	6
Serious TEAEs	1 33.3%	0 0%	2 66.7%	4 100%	2 100%	3 50%	2 33.3%
Non-serious TEAEs	3 100%	3 100%	3 100%	4 100%	2 100%	6 100%	6 100%

17. Secondary Outcome

Title	Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL by the Lugano Classification for Lymphoma
Description	Overall response rate is defined as the percentage of participants with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review board.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination.

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

18. Secondary Outcome

Title	Part 3: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	Overall response rate is defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

19. Secondary Outcome

Title	Part 3: Duration of Tumor Response (DOR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	DOR defined as time from initial documentation of tumor response (CR or PR) to disease progression.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

20. Secondary Outcome

Title	Part 3: Disease Control Rate (DCR) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	DCR defined as percentage of participants who have achieved CR, PR and stable disease.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

21. Secondary Outcome

Title	Part 3: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

22. Secondary Outcome

Title	Part 3: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of tmax of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

23. Secondary Outcome

Title	Part 3: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

24. Secondary Outcome

Title	Part 3: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

25. Secondary Outcome

Title	Part 3: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

26. Secondary Outcome

Title	Part 3: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

27. Secondary Outcome

Title	Part 3: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Description	Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

28. Secondary Outcome

Title	Part 3: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Description	Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

29. Secondary Outcome

Title	Part 3: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Description	Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

30. Secondary Outcome

Title	Part 3: Number of Participants With ADA When Treated With MT-3724
Description	Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 3: All MT-3724 Treated Participants
Arm/Group Description	MT-3724 was administered at a dose of 50µg/kg/dose via IV infusion for all participants
Measure Participants	0

31. Secondary Outcome

Title	Part 4: DOR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	Duration of response was defined as the time from the first occurrence of either complete or partial response to first documented evidence of disease recurrence or progression. Participants without evidence of progression were planned to be censored at time of last disease assessment. Only responders (CR or PR) were planned to be included for this analysis.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

32. Secondary Outcome

Title	Part 4: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs
Description	An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

33. Secondary Outcome

Title	Part 4: Number of Participants With SAEs
Description	A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, any other situation such as important medical events according to medical or scientific judgement or is associated with liver injury and impaired liver function.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

34. Secondary Outcome

Title	Part 4: Number of Participants With Clinically Significant Laboratory Parameters
Description	Blood samples were planned to be collected for the analysis of laboratory parameters.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

35. Secondary Outcome

Title	Part 4: Number Participants With Clinically Significant Vital Signs
Description	Vital signs parameters including systolic and diastolic blood pressure, heart rate, respiration rate, body temperature and body weight were planned to be analyzed.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Safety Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

36. Secondary Outcome

Title	Part 4: Number of Participants With Clinically Significant ECG Values
Description	Standard resting 12-lead ECG assessments was planned to be performed after the participant has rested quietly for at least 5 minutes in supine or semi-recumbent position.
Time Frame	Up to Day 26

Outcome Measure Data

Analysis Population Description

Safety Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

37. Secondary Outcome

Title	Part 4: Number of Participants With Adverse Events Suggestive of Cardiotoxicity
Description	Number of participants with any adverse events leading to cardiotoxicity when treated with MT-3724 was planned to be analyzed.
Time Frame	Up to Day 26

Outcome Measure Data

Analysis Population Description

Safety Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

38. Secondary Outcome

Title	Part 4: ORR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	Overall response rate was defined as the percentage of participants with either a CR or a PR as determined by investigator assessment.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

39. Secondary Outcome

Title	Part 4: DCR in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	DCR was defined as percentage of participants who has achieved CR, PR and stable disease.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

40. Secondary Outcome

Title	Part 4: Progression-free Survival (PFS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	Progression-free survival was defined as the time from study enrollment to the earliest date of disease progression or death from any cause.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

41. Secondary Outcome

Title	Part 4: Overall Survival (OS) in MT-3724 Treated Participants With Relapsed or Refractory DLBCL
Description	Overall survival was defined as the time from study enrollment to death from any cause.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Full Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

42. Secondary Outcome

Title	Part 4: Cmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of Cmax of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

43. Secondary Outcome

Title	Part 4: Tmax of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of Tmax of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

44. Secondary Outcome

Title	Part 4: AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of AUC (0-4), AUC (0-infinity) and AUClast of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

45. Secondary Outcome

Title	Part 4: t1/2 of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of t1/2 of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

46. Secondary Outcome

Title	Part 4: Vz of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of Vz of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

47. Secondary Outcome

Title	Part 4: CL of MT-3724 Monotherapy in Participants With Relapsed or Refractory DLBCL
Description	Blood samples were planned to be collected at indicated timepoints for the analysis of CL of MT-3724 monotherapy.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

48. Secondary Outcome

Title	Part 4: PD of MT-3724 Measured by B-cell Count in Participants With Relapsed or Refractory DCBCL
Description	Pharmacodynamics of MT-3724 was planned to be measured by B-cell count in participants with relapsed of refractory DCBCL using flow cytometry.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

49. Secondary Outcome

Title	Part 4: PD of MT-3724 Measured by Immunophenotyping in Participants With Relapsed or Refractory DCBCL
Description	Pharmacodynamics of MT-3724 was planned to be measured by immunophenotyping in participants with relapsed of refractory DCBCL using flow cytometry.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

50. Secondary Outcome

Title	Part 4: PD of MT-3724 Measured by Circulating Immunoglobulins in Participants With Relapsed or Refractory DCBCL
Description	Pharmacodynamics of MT-3724 was planned to be measured by circulating immunoglobulins in participants with relapsed of refractory DCBCL.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

51. Secondary Outcome

Title	Part 4: Number of Participants With ADA When Treated With MT-3724
Description	Blood samples were planned to be collected to analyze the presence of ADA that bind MT-3724.
Time Frame	Up to Day 45

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Analysis Set. The data was not collected due to early study termination

Arm/Group Title	Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
Measure Participants	0

Adverse Events

Time Frame	Non-serious TEAEs and SAEs were collected up to Day 45.
Adverse Event Reporting Description	Non-serious TEAEs and SAEs were collected in Safety Set and categorized using Common Terminology Criteria for Adverse Events (CTCAE) grade (1 to 5) where each grade is classified as grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening and grade 5=fatal. Number of participants with worst case grade >=3 TEAEs and non-serious TEAEs has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately.
Arm/Group Title	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day		Part 1: Cohort 2: 10 mcg/kg/Dose/Day		Part 1: Cohort 3: 20 mcg/kg/Dose/Day		Part 1: Cohort 4: 50 mcg/kg/Dose/Day		Part 1: Cohort 5: 100 mcg/kg/Dose/Day		Part 1: Cohort 6: 75 mcg/kg/Dose/Day		Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)		Part 3: All MT-3724 Treated Participants		Part 4: All MT-3724 Treated Participants
Arm/Group Description	Participants in this cohort received 5 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.		Participants in this cohort received 10 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.		Participants in this cohort received 20 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.		Participants in this cohort received 50 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.		Participants in this cohort received 100 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.		Participants in this cohort received 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 for the first cycle of experimental drug followed by 9 days observation (Days 13 - 21) for a maximum of 6 cycles.		Participants in this cohort received either 50 or 75 mcg/kg/dose/day on Days 1, 3, 5, 8, 10, and 12 days of 21-Day cycle up to 4 additional cycles to explore safety, tolerability and tumor response to repeat doses of MT-3724.		Participants in this arm received all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle		Participants in this arm were planned to receive all doses of MT-3724 as IV infusion over 1 hour in a 21-day cycle
All Cause Mortality
	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day		Part 1: Cohort 2: 10 mcg/kg/Dose/Day		Part 1: Cohort 3: 20 mcg/kg/Dose/Day		Part 1: Cohort 4: 50 mcg/kg/Dose/Day		Part 1: Cohort 5: 100 mcg/kg/Dose/Day		Part 1: Cohort 6: 75 mcg/kg/Dose/Day		Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)		Part 3: All MT-3724 Treated Participants		Part 4: All MT-3724 Treated Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Serious Adverse Events
	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day		Part 1: Cohort 2: 10 mcg/kg/Dose/Day		Part 1: Cohort 3: 20 mcg/kg/Dose/Day		Part 1: Cohort 4: 50 mcg/kg/Dose/Day		Part 1: Cohort 5: 100 mcg/kg/Dose/Day		Part 1: Cohort 6: 75 mcg/kg/Dose/Day		Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)		Part 3: All MT-3724 Treated Participants		Part 4: All MT-3724 Treated Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/3 (33.3%)		0/3 (0%)		2/3 (66.7%)		4/4 (100%)		2/2 (100%)		3/6 (50%)		2/6 (33.3%)		3/11 (27.3%)		0/0 (NaN)
Blood and lymphatic system disorders
Febrile neutropenia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Iron deficiency anaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Thrombocytopenia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Cardiac disorders
Acute coronary syndrome	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Acute myocardial infarction	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Atrial fibrillation	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Cardiac arrest	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Gastrointestinal disorders
Abdominal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Ascites	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Gastric haemorrhage	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Ileus	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
General disorders
Fatigue	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Oedema	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/0 (NaN)
Oedema peripheral	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Fever	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Infections and infestations
Bronchitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		2/6 (33.3%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Pneumonia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		1/6 (16.7%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Superinfection	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Viral infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Metabolism and nutrition disorders
Dehydration	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypercalcaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Back pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Muscular weakness	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Nervous system disorders
Aphasia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Psychiatric disorders
Anxiety	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Renal and urinary disorders
Renal failure acute	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Acute kidney injury	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Vascular disorders
Hypertension	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Capillary leak syndrome	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		2/11 (18.2%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day		Part 1: Cohort 2: 10 mcg/kg/Dose/Day		Part 1: Cohort 3: 20 mcg/kg/Dose/Day		Part 1: Cohort 4: 50 mcg/kg/Dose/Day		Part 1: Cohort 5: 100 mcg/kg/Dose/Day		Part 1: Cohort 6: 75 mcg/kg/Dose/Day		Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose)		Part 3: All MT-3724 Treated Participants		Part 4: All MT-3724 Treated Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/3 (100%)		3/3 (100%)		3/3 (100%)		4/4 (100%)		2/2 (100%)		6/6 (100%)		6/6 (100%)		11/11 (100%)		0/0 (NaN)
Blood and lymphatic system disorders
Anaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		2/4 (50%)		1/2 (50%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Leukocytosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Leukopenia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Lymph node pain	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Neutropenia	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Pancytopenia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Thrombocytopenia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Granulocytopenia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Iron deficiency anemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Lymphopenia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Cardiac disorders
Angina pectoris	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Cardiomyopathy	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Coronary artery disease	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Myocardial ischaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Palpitations	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Tachycardia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Ear and labyrinth disorders
Ear disorder	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Ear pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Vertigo	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Eye disorders
Diplopia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Eye irritation	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Eye swelling	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Dry eye	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Lacrimation increased	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Retinal exudates	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Retinal haemorrhage	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Vision blurred	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Gastrointestinal disorders
Abdominal distension	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Abdominal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Anal haemorrhage	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Ascites	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Asthenia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Constipation	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Diarrhoea	2/3 (66.7%)		0/3 (0%)		0/3 (0%)		2/4 (50%)		1/2 (50%)		3/6 (50%)		3/6 (50%)		4/11 (36.4%)		0/0 (NaN)
Dyspepsia	1/3 (33.3%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Dysphagia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		1/6 (16.7%)		1/6 (16.7%)		1/11 (9.1%)		0/0 (NaN)
Gastric ulcer	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Gastritis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Gastrooesophageal reflux disease	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Haemorrhoids	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Melaena	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Mouth haemorrhage	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Nausea	1/3 (33.3%)		3/3 (100%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		2/6 (33.3%)		1/6 (16.7%)		1/11 (9.1%)		0/0 (NaN)
Oral pain	0/3 (0%)		2/3 (66.7%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Reflux gastritis	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Stomatitis	1/3 (33.3%)		2/3 (66.7%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Vomiting	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
General disorders
Anemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		5/11 (45.5%)		0/0 (NaN)
Asthenia	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Chills	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Face oedema	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Fatigue	3/3 (100%)		1/3 (33.3%)		2/3 (66.7%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		2/6 (33.3%)		2/11 (18.2%)		0/0 (NaN)
Infusion site irritation	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Injection site extravasation	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Injection site reaction	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Local swelling	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Malaise	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Mucosal inflammation	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		2/6 (33.3%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Muscular weakness	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		2/11 (18.2%)		0/0 (NaN)
Non-cardiac chest pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Oedema	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/0 (NaN)
Oedema peripheral	1/3 (33.3%)		3/3 (100%)		0/3 (0%)		4/4 (100%)		1/2 (50%)		4/6 (66.7%)		3/6 (50%)		4/11 (36.4%)		0/0 (NaN)
Pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Pyrexia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		1/2 (50%)		3/6 (50%)		1/6 (16.7%)		6/11 (54.5%)		0/0 (NaN)
Swelling face	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Hepatobiliary disorders
Hyperbilirubinaemia	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Infections and infestations
Bronchitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Cellulitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Conjunctivitis	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Folliculitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Oral candidiasis	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Oropharyngeal candidiasis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Otitis media	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Pharyngitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Pneumonia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Pyoderma	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Respiratory syncytial virus infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Upper respiratory tract infection	0/3 (0%)		0/3 (0%)		2/3 (66.7%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Urinary tract infection	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Injury, poisoning and procedural complications
Contusion	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Scratch	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Wound	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Investigations
Alanine aminotransferase increased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Aspartate aminotransferase increased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Blood alkaline phosphatase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Blood chloride increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Blood lactic acid increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Gamma-glutamyltransferase increased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Heart rate increased	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Lipase increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Lymphocyte count decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		0/6 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/0 (NaN)
Neutrophil count decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Platelet count decreased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Troponin increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Weight increased	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		3/6 (50%)		1/11 (9.1%)		0/0 (NaN)
White blood cell count decreased	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Metabolism and nutrition disorders
Decreased appetite	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		2/11 (18.2%)		0/0 (NaN)
Dehydration	0/3 (0%)		0/3 (0%)		0/3 (0%)		2/4 (50%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Failure to thrive	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Gout	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hyperglycaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hyperkalaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypoalbuminaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		2/4 (50%)		1/2 (50%)		0/6 (0%)		2/6 (33.3%)		4/11 (36.4%)		0/0 (NaN)
Hypocalcaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypoglycaemia	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypokalaemia	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Hypomagnesaemia	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hyponatraemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		2/2 (100%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypoproteinaemia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		2/11 (18.2%)		0/0 (NaN)
Musculoskeletal and connective tissue disorders
Arthralgia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		3/6 (50%)		1/11 (9.1%)		0/0 (NaN)
Back pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Bone pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Groin pain	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Muscle spasms	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Muscular weakness	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Musculoskeletal pain	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Myalgia	1/3 (33.3%)		2/3 (66.7%)		1/3 (33.3%)		0/4 (0%)		2/2 (100%)		2/6 (33.3%)		3/6 (50%)		7/11 (63.6%)		0/0 (NaN)
Neck pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Tumor pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Nervous system disorders
Dizziness	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		2/4 (50%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		2/11 (18.2%)		0/0 (NaN)
Dysgeusia	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/4 (25%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Headache	2/3 (66.7%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		1/6 (16.7%)		2/6 (33.3%)		1/11 (9.1%)		0/0 (NaN)
Horner's syndrome	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Hyperaesthesia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Hypoaesthesia	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Memory impairment	0/3 (0%)		1/3 (33.3%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Neuropathy peripheral	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Paraesthesia	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Peripheral sensory neuropathy	1/3 (33.3%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Presyncope	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Somnolence	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Psychiatric disorders
Agitation	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Anxiety	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Depression	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Dysphoria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Insomnia	1/3 (33.3%)		1/3 (33.3%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		3/6 (50%)		2/6 (33.3%)		1/11 (9.1%)		0/0 (NaN)
Renal and urinary disorders
Acute kidney injury	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Pollakiuria	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Respiratory, thoracic and mediastinal disorders
Cough	2/3 (66.7%)		1/3 (33.3%)		1/3 (33.3%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Dysphonia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Dyspnoea	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		1/6 (16.7%)		3/11 (27.3%)		0/0 (NaN)
Dyspnoea exertional	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Epistaxis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Hiccups	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		1/2 (50%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypocapnia	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Laryngeal inflammation	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Nasal congestion	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Oropharyngeal pain	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		4/6 (66.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Pleural effusion	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		1/11 (9.1%)		0/0 (NaN)
Pneumonitis	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Pulmonary embolism	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Pulmonary hypertension	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Respiratory tract congestion	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Throat irritation	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Wheezing	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		2/6 (33.3%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Skin and subcutaneous tissue disorders
Acne	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Blister	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Cold sweat	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Dermatitis acneiform	1/3 (33.3%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Ecchymosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Erythema	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		2/6 (33.3%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Hyperhidrosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Night sweats	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Pruritus	0/3 (0%)		0/3 (0%)		1/3 (33.3%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Rash	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Rash maculo-papular	2/3 (66.7%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		2/6 (33.3%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Skin exfoliation	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Skin lesion	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Vascular disorders
Capillary leak syndrome	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		2/6 (33.3%)		1/11 (9.1%)		0/0 (NaN)
Deep vein thrombosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		1/11 (9.1%)		0/0 (NaN)
Flushing	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Haematoma	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hot flush	0/3 (0%)		1/3 (33.3%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)
Hypertension	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Hypotension	0/3 (0%)		0/3 (0%)		0/3 (0%)		1/4 (25%)		0/2 (0%)		2/6 (33.3%)		3/6 (50%)		1/11 (9.1%)		0/0 (NaN)
Lymphoedema	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		1/6 (16.7%)		0/11 (0%)		0/0 (NaN)
Phlebitis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		0/6 (0%)		2/6 (33.3%)		0/11 (0%)		0/0 (NaN)
Venous thrombosis	0/3 (0%)		0/3 (0%)		0/3 (0%)		0/4 (0%)		0/2 (0%)		1/6 (16.7%)		0/6 (0%)		0/11 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.