Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms

JRCT ID: jRCT2041220067

Registered date:04/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mature B-cell lymphomas
• Date of first enrollment: 25/11/2022
• Target sample size: 15
• Countries of recruitment: US,Japan,Australia,Japan,Belgium,Japan,Canada,Japan,Czechia,Japan,France,Japan,Germany,Japan,Israel,Japan,Italy,Japan,Republic of Korea,Japan,Netherlands,Japan,Spain,Japan,Taiwan,Japan,Turkey,Japan
• Study type: Interventional
• Intervention(s): Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.

Outcome(s)

• Primary Outcome: Adverse Events, Cmax, AUC
• Secondary Outcome: Complete Response (CR) per the International Pediatric Non-Hodgkin Lymphoma Response Criteria, Event-free survival, Overall survival, Rate of initiation of stem cell transplantation or chimeric antigen receptor T-cell (CAR-T) therapy, Overall response, Duration of response, Duration of CR, Immunogenicity

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: <= 25age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Yamagishi Chika
• Secondary ID(s): NCT05206357