Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With R/R B-NHL

  • End date
    Sep 30, 2024
  • participants needed
  • sponsor
Updated on 18 August 2021
ct scan
monoclonal antibodies
measurable disease
follicular lymphoma
monoclonal protein
diffuse large b-cell lymphoma
b-cell lymphoma
marginal zone lymphoma
large b-cell lymphoma


The purpose of the trial is to determine the maximum tolerated dose and/or the recommended phase 2 dose as well as to establish the safety profile of epcoritamab in Japanese patients with Relapsed, Progressive or Refractory B-Cell Lymphomas.


The trial is an open-label, multi-center safety trial of epcoritamab. The trial consists of two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined in Part 1.

Condition Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma, MALT Lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, Primary Mediastinal Large B Cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, b-cell small lymphocytic lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma
Treatment Epcoritamab
Clinical Study IdentifierNCT04542824
Last Modified on18 August 2021


Yes No Not Sure

Inclusion Criteria

Must be at least 20 years of age, inclusive
Japanese subjects
Documented CD20 positive mature B-cell neoplasm
Part 1 - dose escalation
Diffuse large B-cell lymphoma (de novo or histologically transformed)
High-grade B-cell lymphoma
Primary mediastinal large B-cell lymphoma
Follicular lymphoma
Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid tissue, or splenic)
Small lymphocytic lymphoma 2. Part 2 - expansion
Diffuse large B-cell lymphoma (de novo or histologically transformed)
Follicular lymphoma grade 1-3A
Relapsed or refractory disease and previously treated with at least 2 lines of systemic antineoplastic therapy including at least 1 anti-CD20 mAb-containing therapy
Measurable disease by CT, MRI or PET-CT scan

Exclusion Criteria

Primary CNS lymphoma or CNS involvement by lymphoma
Subjects not eligible for high dose therapy with autologous hematopoietic stem cell transplantation due to personal choice, social issues, or similar
AST and/or ALT > 3 xULN
Total bilirubin > 1.5 xULN (unless due to Gilbert syndrome)
Creatinine clearance < 45 mL/min
Known clinically significant cardiac disease
Chronic ongoing infectious diseases requiring treatment (excluding prophylactic treatment)
Exposed to live or live attenuated vaccine within 4 weeks before the first dose of epcoritamab
Active hepatitis B (HepB DNA positive) or hepatitis C (HepC RNA positive)
Known history or positive test results confirming HIV infection
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