Phase 1 Study of Dual-target BCMA-GPRC5D CAR-T Cell Therapy for Relapsed or Refractory Multiple Myeloma with Extramedullary Infiltration

What this Trial Is About

Researchers are evaluating the safety of a dual-targeting BCMA and GPRC5D CAR-T cell therapy for patients with relapsed or refractory multiple myeloma who have extramedullary infiltration. This phase 1, multicenter, open-label, non-randomized, single-arm trial aims to assess dose-limiting toxicity and adverse events within one month after reinfusion of the CAR-T cells. The study expects to recruit up to 18 participants. Participants receive a lymphodepletion treatment with fludarabine and cyclophosphamide about 3 to 5 days before the CAR-T cell infusion. The dual-targeting BCMA-GPRC5D CAR-T cells are then infused 48 hours after completing chemotherapy. This single treatment approach focuses on targeting the cancer cells expressing BCMA and GPRC5D. During the study, participants will be monitored for dose-limiting toxicities and any adverse events occurring within 30 days after the CAR-T cell infusion. Researchers will also assess overall remission rates at 90 days and track event-free survival, duration of response, and overall survival for up to two years after enrollment. This thorough follow-up includes clinical evaluations and safety monitoring to understand the therapys impact over time.

Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration