NCT07003555

Dual-target BCMA-CD19 CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration

Practical Clinical Study of Dual-targeting BCMA-CD19 CAR-T Cell Therapy for Extramedullary Infiltration in Refractory/Relapsed Multiple Myeloma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Beijing GoBroad Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 - CD19 CAR-T cell therapy. The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and CD19 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 infusion of BCMA-CD19 CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the infusion. It is expected that no more than 18 participants will be recruited.

Conditions

• Relapsed or Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
DRUG	Dual-targeting BCMA-CD19 CAR-T cell infusion	Approximately 3-5 days prior to BCMA-CD19 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Timeline

• Start date: 2025-05-25
• Primary completion: 2027-05-25
• Completion: 2027-06-25
• First posted: 2025-06-04
• Last updated: 2025-11-26

Locations

1 site across 1 country: China