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OncoMatch/Clinical Trials/NCT07003568

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

Is NCT07003568 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Dual-targeting BCMA-GPRC5D CAR-T cell infusion for relapsed or refractory multiple myeloma (rrmm).

Phase 1RecruitingBeijing GoBroad HospitalNCT07003568Data as of May 2026

Treatment: Dual-targeting BCMA-GPRC5D CAR-T cell infusionThis 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.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Biomarker criteria

Required: BCMA positive by flow cytometry or immunohistochemistry

Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue

Required: GPRC5D positive by flow cytometry or immunohistochemistry

Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: CAR-T cell therapy

Exception: vector with the same structure

Previous use of a CAR - T vector with the same structure

Lab requirements

Kidney function

creatinine clearance rate ≥ 40 ml/min (by cockcroft and gault formula)

Liver function

alanine aminotransferase and aspartate aminotransferase < 3 times the upper limit of normal (uln)

Cardiac function

left ventricular ejection fraction > 50% (by echocardiogram) in the past 2 weeks

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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