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


Description

The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. 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 Burki

Trial Eligibility

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. 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.

Study Info

Organization

Genmab


Primary Outcome

Number of Participants with Adverse Events (AE)


Outcome Timeframe Up to Approximately 3 Years

NCTID NCT05206357

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2022-10-04

Completion Date 2028-11

Enrollment Target 15

Interventions

DRUG Epcoritamab

Locations Recruiting

Lucile Packard Children's Hospital /ID# 240854

United States, California, Palo Alto


Nicklaus Children's Hospital /ID# 241174

United States, Florida, Miami


New York Medical College /ID# 239208

United States, New York, Valhalla


Levine Children's Hospital /ID# 242765

United States, North Carolina, Charlotte


Cincinnati Childrens Hospital Medical Center /ID# 239823

United States, Ohio, Cincinnati


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