Results from CARTITUDE-1: A Phase 1b/2 Study of JNJ-4528, a CAR-T Cell Therapy Directed Against B-Cell Maturation Antigen (BCMA), in Patients with RRMM
Introduction: JNJ-68284528 (JNJ-4528) is a chimeric antigen receptor T cell (CAR-T) therapy containing two BCMA-targeting single-domain antibodies designed to confer avidity. A first-in-human phase 1 study (LEGEND-2) conducted in China of LCAR-B38M, an identical CAR to JNJ-4528, showed high overall response and manageable safety in 74 patients (pts) with R/R MM. Phase 1b results from the ongoing CARTITUDE-1 study conducted in the US with JNJ-4528 are presented here (NCT03548207).
Conclusion: Collectively these results demonstrate that JNJ-4528 at a target dose of 0.75x106 CAR+ cells/kg delivers early and deep responses, including MRD negativity in all evaluable pts tested, with a manageable safety profile in pts with refractory MM. The safety and efficacy results from the ongoing CARTITUDE-1 study are consistent with the LEGEND-2 study and confirm the 0.75x106 CAR+ cells/kg dose as the RP2D for further clinical development.