Timothy Voorhees
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.
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 es…
Inclusion Criteria: * 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. * Subjects are eligible with prior immunosuppression reduction (ISR) o…
Undergo biopsy
Undergo blood sample collection
Undergo PET/CT
Given SC
Undergo PET/CT