Phase 3 Trial Comparing Rondecabtagene Autoleucel Versus Investigators Choice CD19 CAR T-Cell Therapy for Relapsed or Refractory Large B-Cell Lymphoma in Second-Line Treatment

What this Trial Is About

Researchers are evaluating rondecabtagene autoleucel ronde-cel, a dual-targeting CD19CD20 CAR T-cell therapy, in a Phase 3 randomized controlled trial for patients with relapsed or refractory large B-cell lymphoma who did not respond to first-line anti-CD20 antibody and anthracycline chemotherapy. The study compares ronde-cel with the investigators choice of currently approved CD19 CAR T-cell therapies, axicabtagene ciloleucel axi-cel or lisocabtagene maraleucel liso-cel, to assess efficacy and safety in the second-line setting. This trial addresses challenges like disease progression due to CD19 antigen loss or T-cell exhaustion seen with existing therapies. Participants will be randomly assigned to receive either ronde-cel or the investigators choice of axi-cel or liso-cel. Both treatments are autologous CAR T-cell therapies given as a single intravenous infusion after lymphodepletion with fludarabine and cyclophosphamide. Ronde-cel is designed to target both CD19 and CD20 antigens to improve response durability. Approximately 400 patients will be enrolled and followed for safety and effectiveness for 3 years, with long-term follow-up extending up to 15 years. During the study, participants will undergo assessments including PETCT scans to measure disease status, along with evaluations of overall response, progression-free survival, and adverse events. Researchers will closely monitor event-free survival over 36 months as the primary outcome. Participants will have regular visits during treatment and follow-up periods to track outcomes and safety. The trial will continue gathering data on survival and side effects for up to 6 years and beyond to understand long-term effects.

A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy