Panelists discuss how the CARTITUDE-1 trial was designed to evaluate cell therapy in relapsed/refractory multiple myeloma (RRMM) and the importance of long-term follow-up in understanding efficacy and safety.
The CARTITUDE-1 study is introduced as a phase 1b/2 trial evaluating ciltacabtagene autoleucel (cilta-cel) in patients with RRMM. Eligible participants had triple-class exposure, prior treatment failure, and good performance status, reflecting a heavily pretreated population.
The process involved leukapheresis, bridging therapy during chimeric antigen receptor (CAR) T-cell manufacturing, lymphodepleting chemotherapy, and a single cilta-cel infusion. A long-term extension study, CARTITUDE-Long-Term (CARTITUDE-LT), tracks patients for up to 15 years to monitor efficacy and emerging safety signals.
This rigorous trial design enables researchers to determine the longevity of response and identify any late-onset toxicities. It lays the groundwork for establishing benchmarks in long-term disease control and understanding CAR T-cell persistence.