Phase Ib Study to Assess the Efficacy and Safety of Epcoritamab in Relapsed or Refractory Post-Transplant Lymphoproliferative Disorder
Timothy Voorhees
Summary
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.
Description
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…