Odronextamab Treatment Before CAR-T Therapy for Adults with Relapsed or Refractory Large B-Cell Lymphomas

What this Trial Is About

Researchers are evaluating the use of odronextamab as bridging therapy before chimeric antigen receptor T CAR-T cell therapy in adults with relapsed or refractory large B-cell lymphomas. Odronextamab is a bispecific antibody that targets CD3 on T-cells and CD20 on B-cells, potentially interfering with cancer cell growth. Bridging therapy given before leukapheresis aims to delay disease progression and improve the chances of successful CAR-T cell therapy in these patients. Patients receive odronextamab intravenously with a step-up dosing schedule in cycle 1, followed by weekly doses in cycles 2 to 4, and then every other week for up to 12 months total. After 2 cycles, leukapheresis is performed followed by lymphodepletion and CAR-T infusion according to standard care. If leukapheresis is delayed, up to 12 additional weeks of odronextamab may be given. Patients achieving complete response after 2 cycles may opt out of leukapheresis and CAR-T infusion and continue odronextamab if no disease progression or unacceptable toxicity occurs. During the study, participants undergo PETCT scans, blood and oral or rectal swab sample collection, tissue biopsy, and possibly lumbar puncture and bone marrow aspiration or biopsy. After treatment completion, participants are followed for toxicity monitoring until 90 days or the start of new lymphoma therapy, with total follow-up up to 5 years. The primary outcome is failure to undergo leukapheresis, with additional assessments including response rates, progression-free survival, and adverse event incidence.

Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T