Epcoritamab

PRIMARY OBJECTIVE: I. To assess the safety of treatment with epcoritamab in subjects with PTLD. SECONDARY OBJECTIVES: I. To estimate the Objective Response Rate (ORR), defined as the clinical response (complete response [CR] + partial response [PR]) after 3 cycles of epcoritamab. II. To estimate the clinical benefit rate (CBR) in subjects with PTLD treated with epcoritamab. III.

To estimate the best objective response rate (BOR) in subjects with PTLD treated with epcoritamab. IV. To estimate the progression free survival (PFS) in subjects with PTLD treated with epcoritamab. V. To estimate the duration of complete response (DoCR) in subjects with PTLD treated with epcoritamab. VI. To estimate the overall survival (OS) in subjects with PTLD treated with epcoritamab. EXPLORATORY OBJECTIVES: I.

This phase Ib trial tests the safety and effectiveness of epcoritamab in treating patients with post-transplant lymphoproliferative disorder (PTLD) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell).

It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Giving epcoritamab may be safe and effective in treating patients with relapsed or refractory B-cell PTLD.

Registro actualizado en ClinicalTrials.gov →

• Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information to the sponsor, sites, and relevant study organizations.
• Age ≥ 18 years at the time of consent.
• Karnofsky scale ≥ 50% or Eastern Cooperative Oncology Group (ECOG) ≤ 2.
• Histological evidence of B-cell PTLD (any histologic subtype) following solid organ transplantation; expresses CD20; with or without EBV association.
• Treatment failure of immunosuppression reduction (ISR). NOTE: if ISR was deemed not feasible by treating physician, ISR treatment failure may be waived.
• Treatment failure of rituximab or rituximab plus any concurrent or sequentially administered chemotherapy regimen.

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.