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

StatusRecruiting
PhasePhase 1
Started2025-05-25
View on ClinicalTrials.gov ↗

Amendment history

2025-11-21
minor
Study Status, Sponsor/Collaborators v2
Collaborators1 to 2 entries
Ruijin Hospital
2025-11-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2025-06-02
minor
Original filing
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.
Trial Details
NCT Number NCT07003555
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