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MINDway: Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Sponsor
MorphoSys AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05222555
Collaborator
(none)
51
Enrollment
20
Locations
1
Arm
55.4
Anticipated Duration (Months)
2.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Actual Study Start Date :
Jul 19, 2022
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
Feb 28, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (Tafasitamab + Lenalidomide)

Treatment: Tafasitamab will be combined with lenalidomide in R/R DLBCL patients. Dose: Cohort 1: The dose of tafasitamab will be level 1 high dose in combination with the approved dose Cohort 2: The dose of tafasitamab will be level 2 high dose in combination with the approved dose Expansion Cohort: The dose of tafasitamab will be the dose that is deemed safe and tolerable as determined from cohort 1 & cohort 2 Treatment consisting of tafasitamab and lenalidomide combination will be administered until disease progression, unacceptable toxicity, or discontinuation for any other reason, whichever comes first. Lenalidomide can be given for up to 12 cycles in total, after which patients can continue with tafasitamab as monotherapy until progression or unacceptable toxicity.

Drug: Tafasitamab
tafasitamab will be administered intravenously at protocol defined timepoints
Other Names:
  • INCMOR00208
  • MOR00208
  • Xmab5574

    • Drug: Lenalidomide
    lenalidomide will be administered orally at protocol defined timepoints

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate safety and tolerability [1 - 3 years approximately]

      Incidence and severity of TEAEs

    2. Determine recommended dose [1 - 3 years approximately]

      Incidence and severity of TEAEs combination with lenalidomide in R/R DLBCL patients

    Secondary Outcome Measures

    1. Evaluate pharmacokinetic profile [Upto 1 year]

      Tafasitamab serum concentration (Ctrough)

    2. Evaluate pharmacokinetic profile [Upto 3 months]

      Tafasitamab serum concentration (Cmax)

    3. Assess anti-tumor activity [upto 1 year]

      Number of participants with Best Objective Response Rate, ORR = complete response [CR] + partial response [PR]; by Investigator assessment based on Cheson et al (2007)

    4. Duration of response (DoR) [1 - 3 years approximatey]

      Investigator assessment

    5. Progression-free Survival (PFS) [1 - 3 years approximately]

      Investigator assessment

    Other Outcome Measures

    1. B cell numbers [upto 1 year]

      Absolute counts and percentage change from baseline in measurement of B cell numbers in peripheral blood

    2. T cell numbers [upto 1 year]

      Absolute counts and percentage change from baseline in measurement of T cell numbers in peripheral blood

    3. NK cell numbers [upto 1 year]

      Absolute counts and percentage change from baseline in measurement of NK cell numbers in peripheral blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Major Inclusion Criteria:

    1. Capable of giving signed informed consent

    2. Age >18 years

    3. Histologically confirmed diagnosis of DLBCL

    4. Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.

    5. Patients must have:

    • relapsed and/or refractory disease

    • at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

    • received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy

    • Eastern Cooperative Oncology Group 0 to 2

    1. Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT

    2. Patients must meet the following laboratory criteria at screening:

    • absolute neutrophil count ≥1.5 × 109/L

    • platelet count ≥90 × 109/L

    • total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma

    • alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement

    • serum creatinine clearance ≥50 mL/minute

    Major Exclusion Criteria:

    1. Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study

    2. Patients who have:

    • other histological type of lymphoma

    • primary refractory DLBCL

    • a history of "double/triple hit" genetics

    1. Patients who have, within 14 days prior to Day 1 dosing:

    • not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy

    • undergone major surgery (with 4 weeks) or suffered from significant traumatic injury

    • received live vaccines (within 4 weeks).

    • required parenteral antimicrobial therapy for active, intercurrent infections

    1. Patients who:

    • have not recovered sufficiently from the adverse toxic effects of prior therapies

    • were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)

    • have history of hyper sensitivity to compounds of similar biological or chemical composition to tafasitamab IMiDs® and/or the excipients contained in the study treatment formulations

    • have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.

    • have undergone previous allogenic stem cell transplantation

    • have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period

    • concurrently use other anticancer or experimental treatments

    1. History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions

    • Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for >2 years prior to enrollment are eligible

    • Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible

    1. Patients with:

    • positive hepatitis B and/or C serology.

    • known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)

    • CNS lymphoma involvement

    • 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 patient's ability to give informed consent

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

    • gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication

    • history or evidence of severe hepatic impairment (total serum bilirubin > 3mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma

    • history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class

    • any other medical condition which, in the investigator's opinion, makes the patient unsuitable for the study

    1. Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vista Oncology Olympia Washington United States 98506
    2 UK St. Pölten Sankt Pölten Niederösterreich Austria 3100
    3 Klinikum Wels Grieskirchen Wels Oberösterreich Austria 4600
    4 Universitatsklinikum Salzburg Salzburg Austria 5020
    5 Fakultni nemocnice Brno Brno Czechia 625 00
    6 Fakultni nemocnice Ostrava Ostrava Czechia 708 52
    7 Fakultni nemocnice Kralovske Vinohrady Praha Czechia 100 34
    8 Fakultni nemocnice v Motole Praha Czechia 150 06
    9 Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon Grenoble Isère France 38043
    10 CHU Nantes Nantes Loire-Atlantique France 44000
    11 Centre Hospitalier Le Mans Le Mans Sarthe France 72000
    12 CHU de Poitiers Poitiers Vienne France 86021
    13 Hospital Son Llatzer Palma de Mallorca Baleares Spain 7198
    14 Hospital U. Infanta Leonor Madrid Spain 28031
    15 MD Anderson Madrid Madrid Spain 28033
    16 Hospital U. Ramon y Cajal Madrid Spain 28034
    17 Hospital U. Quironsalud Madrid Madrid Spain 28223
    18 Complejo Asistencial Universitario de Salamanca - H. Clinico Salamanca Spain 37007
    19 Hospital U. Virgen del Rocio Sevilla Spain 41013
    20 Hospital Universitari La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • MorphoSys AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MorphoSys AG
    ClinicalTrials.gov Identifier:
    NCT05222555
    Other Study ID Numbers:
    • MOR208C115
    First Posted:
    Feb 3, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MorphoSys AG
    monoclonal antibody
    CD19
    tafasitamab
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, B-Cell
    Lymphoma, Large B-Cell, Diffuse
    Lenalidomide

    Study Results

    No Results Posted as of Aug 8, 2022