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

NCT07003555 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-11-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Shanghai Liquan Hospital

    collaborator OTHER

  • Ruijin Hospital

    collaborator OTHER

  • Beijing GoBroad Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-25
Primary Completion
2027-05-25
Completion
2027-06-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07003555 on ClinicalTrials.gov