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OncoMatch/Clinical Trials/NCT05998928

A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With Relapsed/Refractory Multiple Myeloma Who Received Three or More Lines of Therapy

Is NCT05998928 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fludarabine + Cyclophosphamide + BCMA-GPRC5D CAR-T Cells for multiple myeloma.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT05998928Data as of May 2026

Treatment: Fludarabine + Cyclophosphamide + BCMA-GPRC5D CAR-T CellsThis is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D Chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 1–2(Ambulatory, capable of self-care)

Prior therapy

Min 3 prior lines

Must have received: proteasome inhibitor

which at least include: one Proteasome Inhibitor (PI)

Must have received: immunomodulatory drug

which at least include: one Immunomodulatory Drug (IMiD)

Must have received: anti-CD38 monoclonal antibody

which at least include: one anti-CD38 monoclonal antibody

Cannot have received: anti-tumor therapies before apheresis

Patients received previous anti-tumor therapies before apheresis including following therapies: targeted therapies, epigenetics modulation drugs, other drugs or medical devices (invasive) of clinical trials, monoclonal antibodies, cytotoxic agents, PIs, IMiDs, radiotherapy

Lab requirements

Blood counts

Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days

Kidney function

Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min

Liver function

Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN

Cardiac function

Left ventricular ejection fraction (LVEF) > 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance; Baseline peripheral oxygen saturation > 92%; Without clinically significant pleural effusion

Liver, kidney and cardiopulmonary functions meet the following requirements: Total bilirubin ≤ 1.5×ULN, ALT ≤ 3 × ULN and AST ≤ 3 × ULN; Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min; Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days; Baseline peripheral oxygen saturation > 92%; Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or free (ionized, ionic) calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L); Left ventricular ejection fraction (LVEF) > 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance; Without clinically significant pleural effusion

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

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