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M20-429 - A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms


M20-429 - A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

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DiagnosisNon-hodgkin LymphomaStudy StatusOpen
Age1 to 25 Years OldRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Epcoritamab Subcutaneous Injection (SC) Other Name: ABBV-GMAB-3013
Last Posted Update2023-10-18 #NCT05206357
International Sponsor
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Sarah Alexander
CHU Sainte-Justine - Dr. Henrique Bittencourt
Medical contact

Dr. Daniel Morgenstern

Social worker/patient navigator contact

Karen Fung

Clinical research contact

New Agent and Innovative Therapies (NAIT)


Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
Social worker/patient navigator contact
Marie-Claude Charrette
Clinical research contact
Marie Saint-Jacques



Study Description

The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally.

Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment.


Inclusion Criteria
  • Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
  • Disease pathologically confirmed (tumor tissue) by local testing.
  • Relapsed or primary refractory disease meeting any of the following criteria:

    • Progressive disease at any time during second-line chemoimmunotherapy (CIT).
    • Best response of stable disease (SD) after a minimum of 2 cycles of second-line CIT.
    • Best response of partial response (PR) after a minimum of 3 cycles of second-line CIT.
    • Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but unfit or ineligible for consolidation with cell therapy.
    • Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line CIT.
    • Have received cell therapy (allogeneic or autologous transplant or chimeric antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained or maintained a CR.
  • Recovery from toxic effects of prior chemoimmunotherapy.
  • Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2 .
  • Adequate bone marrow, hepatic, and renal function.

Other inclusion criteria may apply

Exclusion Criteria
  • Known central nervous system (CNS) involvement by lymphoma at screening as confirmed by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron emission tomography (PET) brain scans (participants with evidence of CNS disease only in the cerebrospinal fluid (CSF) will be eligible).
  • Other malignancy requiring therapy.
  • Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other investigational agents.

Other exclusion criteria may apply