Phase 2 Study of Epcoritamab With Platinum-Based Chemotherapy and Autologous Stem Cell Transplant in Adults With Relapsed or Refractory Large B-Cell Lymphoma

What this Trial Is About

This trial evaluates the combination of epcoritamab with standard platinum-based chemotherapy and autologous hematopoietic cell transplant autoHCT in adults with relapsed or refractory large B-cell lymphoma LBCL. This phase II study aims to assess the anti-tumor activity and toxicities of this combined treatment in patients whose disease has returned or not responded to prior therapies. Epcoritamab is a bispecific T-cell engager that binds to CD3 on T cells and CD20 on B cells and lymphoma cells, potentially helping the immune system target cancer cells. Participants receive epcoritamab subcutaneously on specific days of each 28-day cycle, combined with physicians choice of platinum-containing chemotherapy regimens such as RICE, RDHAPX, or GemOx before autoHCT, which is performed around week 0. After autoHCT, patients receive consolidation and maintenance epcoritamab for up to 12 additional cycles with varying dosing schedules to continue therapy without disease progression or unacceptable toxicity. Throughout the study, participants undergo imaging tests like CT, PETCT, echocardiography or MUGA scans, and possibly brain MRI or CT at screening. Blood samples are regularly collected for evaluation. After completing treatment, patients are followed for up to two years with visits every four months to monitor outcomes, including complete response rate and safety. The study tracks progression-free survival, overall survival, and minimal residual disease status during this period.

Epcoritamab Plus Standard of Care Platinum-Based Chemotherapy and Autologous Hematopoietic Cell Transplant for the Treatment of Relapsed or Refractory Large B-cell Lymphoma