EPCORE PEDS-1 (Epcoritamap)
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms.
Recruiting
Summary
The purpose of this study is to assess the safety and tolerability of epcoritamab monotherapy in pediatric patients with relapsed/refractory aggressive mature B-cell neoplasms and young adult patients with Burkitt's or Burkitt-like lymphoma/leukemia.
Epcoritamab is a bispecific antibody that binds CD3 on T cells and CD20 on B cells, inducing potent and selective T-cell-mediated killing of malignant CD20+ B cells. Patients will receive subcutaneous epcoritamab in 28-day cycles and will be followed for a minimum of 3 years after enrollment.
Main inclusion criteria
- Age: ≥ 1 to < 18 years at time of primary diagnosis
- Diagnosis with relapsed/refractory:
- Burkitt's or Burkitt-like lymphoma/leukemia,
- Diffuse large B-cell lymphoma (DLBCL),
- or other aggressive mature (CD20+) B-cell lymphomas
Sponsor
AbbVie Germany