Phase 1b Study of Epcoritamab Given by Injection to Treat Adults with Relapsed or Refractory B-Cell Post-Transplant Lymphoproliferative Disorder

What this Trial Is About

Researchers are evaluating the safety and effectiveness of epcoritamab in patients with post-transplant lymphoproliferative disorder PTLD that has returned or not responded to previous treatments. Epcoritamab is a bispecific antibody that targets proteins on T cells and B cells, potentially helping the immune system attack lymphoma cells. This phase Ib trial aims to assess various clinical outcomes, including response rates and survival, in patients with relapsed or refractory B-cell PTLD after organ transplantation. Participants receive epcoritamab through subcutaneous injections on specific days during 28-day cycles, up to 12 cycles total, unless the disease worsens or unacceptable side effects occur. The treatment schedule includes more frequent dosing in the first two cycles and less frequent dosing in later cycles. Patients with complete response may continue treatment if progression occurs within six months, while those with partial response or stable disease continue treatment as long as it remains safe. Additional procedures include PETCT scans, blood sample collections, and possible biopsies during screening. During the study, participants are monitored for side effects, disease progression, and response to treatment through imaging and blood tests. After completing treatment, follow-up occurs 28 days later and then every three months for up to three years. The main outcome measured is the incidence of adverse events up to 30 days after the last dose. Other outcomes include objective response rate, clinical benefit rate, progression-free survival, duration of response, and overall survival, tracked throughout the study period.

Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders