Clinical Trial

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

Recruiting Phase 1
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Summary
This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy. The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-02; most recent amendment 2025-11-21.
Status change: Not Yet Recruiting → Recruiting 2025-11-15
Trial Details
NCT Number NCT07003568
Lead Sponsor Beijing GoBroad Hospital
Collaborators: Shanghai Liquan Hospital, Ruijin Hospital
Conditions Relapsed or Refractory Multiple Myeloma (RRMM)
Enrollment 18 participants
Start Date 2025-05-25
Primary Completion 2027-05-25 (estimated)
Study Completion 2027-06-25 (estimated)
Updated on ClinicalTrials.gov 2025-11-26