J-MIND: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Sponsor
Incyte Biosciences Japan GK (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04661007
Collaborator
(none)
49
Enrollment
5
Locations
3
Arms
35.2
Anticipated Duration (Months)
9.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab anlone in Japanese participants with NHL., or tafasitimab in combination with lenalidomide in in Japanese participants with R/R DLBCL, or tafasitimab in combination with parsaclisib in in Japanese participants with R/R DLBCL or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBCL.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
49 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Open Label
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study of Tafasitamab, Tafasitamab Plus Lenalidomide, Tafasitamab Plus Parsaclisib, and Tafasitamab Plus Lenalidomide in Combination With R-CHOP in Japanese Participants With Non-Hodgkin Lymphoma
Actual Study Start Date :
Dec 15, 2020
Anticipated Primary Completion Date :
Jul 24, 2023
Anticipated Study Completion Date :
Nov 21, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Part 1 : tafasitimab monotherapy

Dose-finding to evaluate the safety and tolerability and to determine the RP2Ds of single-agent tafasitamab in Japanese participants with NHL. Part 1 consists of 2 groups: Group 1 will evaluate weight-based doses of tafasitamab, and Group 2 will evaluate fixed doses of tafasitamab.

Drug: tafasitamab
tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
Other Names:
  • INCMOR00208
  • MOR00208
  • Xmab5574
  • Experimental: Part 2 : tafasitamab combination therapy

    tafasitamab will be combined with lenalidomide (Group 3) or parsaclisib (Group 4a) in R/R DLBCL participants or lenalidomide plus R-CHOP (Group 5) in previously untreated DLBCL participants. The dose of tafasitamab will be based on the weight-based RP2D that is deemed safe and tolerable in Part 1.

    Drug: tafasitamab
    tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
    Other Names:
  • INCMOR00208
  • MOR00208
  • Xmab5574
  • Drug: lenalidomide
    lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.

    Drug: parsaclisib
    parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.

    Drug: R-CHOP
    R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned.

    Experimental: Part 3 : Dose Expansion of tafasitamab +parsaclisib

    tafasitamab in combination with parsaclisib will be further evaluated in Group 4b at RP2D determined in Part 2

    Drug: tafasitamab
    tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
    Other Names:
  • INCMOR00208
  • MOR00208
  • Xmab5574
  • Drug: parsaclisib
    parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.

    Outcome Measures

    Primary Outcome Measures

    1. Part 1,2 and 3 : Treatment Emergent Adverse Events (TEAE'S) [Approximately 2 years]

      Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment.

    Secondary Outcome Measures

    1. Part 1,2, and 3 : Cmax of tafasitamab [Approximately 27 months]

      Maximum observed serum concentration.

    2. Part 1, 2, and 3 : Cmin of tafasitamab [Approximately 27 months]

      Minimum observed serum concentration over the dose interval.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Groups 1 and 2 only: Biopsy-proven participants with relapsed or refractory NHL of DLBCL, FL or MZL..

    • Groups 3, and 4 only: Biopsy-proven participants with relapsed or refractory DLBCL..

    • Groups 5 only: Biopsy-proven participants with relapsed or refractory DLBCL..

    • Participants must have at least 1 bi-dimensionally measurable lesion.

    • -ECOG performance status of 0 to 2.

    • Participants with protocol defined laboratory criteria at screening

    • Groups 1 and 2 only:

    Received at least 1 previous systemic therapy line for the treatment of NHL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).

    -Groups 3, 4a, and 4b only: Received at least 1, but no more than 3, previous systemic therapy lines for the treatment of DLBCL. At least 1 previous therapy line must have included a CD20-targeted therapy (eg, RTX).

    • Group 5 only: Participant must have: a. Untreated DLBCL. b. Ann Arbor Stage III to IV. c. IPI status of 3 to 5 or age-adjusted IPI 2-3 (in Group 5 only). d. Appropriate candidate for R-CHOP. e. LVEF of ≥ 50%, assessed by echocardiography.

    -Willingness to avoid pregnancy or fathering children.

    -In the opinion of investigator, the participant must: a. Not have a history of noncompliance in relation to medical regimens or be considered potentially unreliable and/or uncooperative.

    1. Be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
    Exclusion Criteria:

    -Any other histological type of lymphoma

    • History of prior non-hematologic malignancy

    • Congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.

    • Participants with known positive test result for hepatitis C, and hepatitis B.

    • Known seropositive for or history of active viral infection with HIV.

    • Known active bacterial, viral, fungal, mycobacterial, or other infection at screening.

    • Known CNS lymphoma involvement - present or past medical history.

    • History or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the participant's ability to give informed consent.

    • History or evidence of rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

    • History or evidence of interstitial lung disease.

    • Vaccination with live vaccine within 21 days prior to study treatment (Note: throughout the study treatment period and at least 6 months after end of treatment, vaccination with live vaccines should be avoided).

    • Major surgery within up to 30 days prior to signing the ICF, unless the participant is recovered at the time of signing the ICF.

    • Any anticancer and/or investigational therapy within 14 days prior to the start of Cycle 1

    • Gastrointestinal abnormalities including the inability to take oral study treatment, requiring IV alimentation, or prior surgical procedure affecting absorption.

    • Pregnancy or lactation.

    • Groups 3 and 5 only: Participants who have history of deep venous thrombosis/embolism, threatening thromboembolism, stroke or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period if required

    • Groups 4a and 4b only: Use or expected use during the study of any restricted medications, including potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the date of study treatment administration

    • Groups 1, 2, 3, 4a, and 4b only: Participants who have: a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy, or other lymphoma-specific therapy within the 14 days prior to Day 1 dosing.

    1. In the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies.

    2. Previous treatment with CD19-targeted therapy (eg, CD19-CAR-T therapies, other CD19 mAbs including bispecific and ADCs).

    3. Group 3 only: Been previously treated with IMiDs (eg, thalidomide or LEN). e. Group 4a and 4b only: Been previously treated with selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib) and/or Bruton's tyrosine kinase inhibitors (eg, ibrutinib).

    4. A history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs, and/or the excipients contained in the study treatment formulations (citric acid monohydrate, polysorbate 20, sodium citrate dehydrate and trehalose dihydrate).

    5. Undergone ASCT within the period ≤ 3 months before the signing of the ICF. Participants who have a more distant history of ASCT must exhibit full hematological recovery before enrolment into the study.

    6. Undergone previous allogenic stem cell transplantation. i. Concurrent treatment other anticancer or experimental treatments.

    • Group 5 only: Participants who have: a. A history of radiation therapy to ≥ 25% of the bone marrow for other diseases or history of anthracycline therapy.
    1. A history of hypersensitivity or contraindication to any component of R-CHOP, LEN, or compounds of similar biological or chemical composition as tafasitamab and/or the excipients contained in the study treatment formulations or R-CHOP.

    2. Contraindication to any of the individual components of R-CHOP. d. Any anticancer and/or investigational therapy within 30 days prior to the start of Cycle 1, except for permitted prephase treatment defined below.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Aichi Cancer Center HospitalAichiJapan464 8681
    2National Cancer Center Hospital EastChibaJapan277-8577
    3National Hospital Organization Kyushu Cancer CenterFukuokaJapan811-1395
    4Osaka University HospitalSuita-shiJapan565-0871
    5National Cancer Center HospitalTokyoJapan104-0045

    Sponsors and Collaborators

    • Incyte Biosciences Japan GK

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Biosciences Japan GK
    ClinicalTrials.gov Identifier:
    NCT04661007
    Other Study ID Numbers:
    • INCMOR 0208-102
    First Posted:
    Dec 9, 2020
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Incyte Biosciences Japan GK
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022