PiNACLE-H2HRondecabtagene Autoleucel vs. CD19 CAR T-Cell Therapy in Relapsed or Refractory Large B-Cell Lymphoma

This study is designed to compare two different types of CAR T-cell therapies for patients with large B-cell lymphoma that has returned or not responded to initial treatments. It specifically targets those whose cancer did not improve with standard treatments like anti-CD20 antibody and chemotherapy. The trial evaluates a new treatment called rondecabtagene autoleucel (ronde-cel), which targets both CD19 and CD20 proteins on cancer cells, against current treatments targeting only CD19. This is important because many patients still face disease progression with existing therapies, often due to the cancer cells changing or the therapy becoming less effective over time. By targeting two proteins, ronde-cel aims to provide a more durable response to treatment. Participants in the study will be randomly assigned to receive either the new treatment, ronde-cel, or a current standard treatment chosen by the investigator, which includes options like axi-cel or liso-cel. Before receiving the CAR T-cell therapy, all participants will undergo a preparatory treatment using chemotherapy drugs fludarabine and cyclophosphamide. The CAR T-cell therapy itself is given through a single infusion into a vein. Participants will be carefully monitored for three years to assess how effective the treatments are and to ensure their safety, with additional follow-up for up to 15 years to track long-term effects. The aim is to see if ronde-cel can lead to better outcomes by staying active against the cancer longer.