A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel, a Dual-targeting CD19/CD20 CAR T-Cell Therapy, Versus Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, compared to the investigator's choice of CD19 CAR T-cell therapies in patients with relapsed or refractory large B-cell lymphoma after first-line treatment. This Phase 3 randomized controlled trial aims to assess the effectiveness and safety of these treatments in the second-line setting, addressing challenges such as disease progression due to antigen loss or T-cell exhaustion. Participants will be randomly assigned to receive either ronde-cel or one of the approved CD19 CAR T-cell therapies, axicabtagene ciloleucel (axi-cel) or lisocabtagene maraleucel (liso-cel). All CAR T-cell therapies will be given as a single intravenous infusion following lymphodepleting chemotherapy with fludarabine and cyclophosphamide. Approximately 400 participants will be enrolled, and those treated will be followed for 3 years for safety and efficacy, with extended long-term monitoring up to 15 years. During the study, participants will undergo regular assessments to monitor event-free survival at 36 months, overall and complete response rates, progression-free survival, overall survival up to 6 years, and the incidence and severity of adverse events. These evaluations will include imaging and clinical exams to track disease status and treatment effects. The study involves no masking, and participants will be closely monitored throughout the trial and long-term follow-up periods to understand the durability and safety of the therapies.

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