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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Chemotherapy

Fludarabine + Cyclophosphamide + BCMA-GPRC5D CAR-T Cells

Cancer type

Multiple Myeloma

Performance status

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

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT05998928 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-tumor therapies before apheresis disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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