RecruitingPhase 1NCT07003555

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

Sponsor

Beijing GoBroad Hospital

Enrollment

18 participants

Start Date

May 25, 2025

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy that targets two proteins — BCMA and CD19 — in patients with multiple myeloma that has come back or stopped responding to treatment and has spread outside the bone marrow (called extramedullary disease). CAR-T therapy involves reprogramming your own immune cells to attack cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have relapsed or refractory multiple myeloma with measurable disease outside the bone marrow - Your cancer cells test positive for BCMA - Your heart, liver, kidney, and lung function meet required levels - Your overall functional status is adequate (ECOG ≤ 2) - Your expected survival is more than 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an uncontrolled active infection - You have an active autoimmune disease - Your organ function does not meet required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDual-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.