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OncoMatch/Clinical Trials/NCT05594797

Human BCMA Targeted T Cells Injection(BCMA CAR-T)for Subjects With R/R MM

Is NCT05594797 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Human BCMA Targeted T Cells for multiple myeloma.

Phase 2RecruitingHrain Biotechnology Co., Ltd.NCT05594797Data as of May 2026

Treatment: Human BCMA Targeted T CellsA Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection(BCMA CAR-T) Therapy for R/R MM. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

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

Prior therapy

Min 3 prior lines

Must have received: proteasome inhibitor

Patients have received at least 3 prior MM treatment regimens containing at least one proteasome inhibitor and one immunomodulator

Must have received: immunomodulator

Patients have received at least 3 prior MM treatment regimens containing at least one proteasome inhibitor and one immunomodulator

Cannot have received: CAR-T cell therapy

Subjects who have received CAR-T treatment or other genetically modified cell therapies

Cannot have received: BCMA-targeted therapy

as well as other BCMA-targeting drugs

Cannot have received: hematopoietic stem cell transplant

Exception: autologous transplant is not possible or relapsed after autologous transplant is allowed; any hematopoietic stem cell transplant performed within the first two months of screening is excluded

Subjects with any hematopoietic stem cell transplant performed within the first two months of screening

Cannot have received: immunosuppressive therapy

Exception: due to graft-versus-host disease performed during the screening period

any immunosuppressive therapy due to graft-versus-host disease performed during the screening period

Cannot have received: systemic steroid

Exception: except inhalation or topical use

Subjects who were receiving systemic steroid treatment within 14 days before the screening period and who were judged by the investigator to require long-term use of systemic steroid therapy during treatment (except inhalation or topical use)

Cannot have received: systemic anti-tumor therapy

Exception: except for local anti-tumor therapy

subjects who received any systemic anti-tumor therapy (except for local anti-tumor therapy)

Cannot have received: live attenuated vaccine

Subjects who have received live attenuated vaccine within 4 weeks prior to apheresis

Lab requirements

Blood counts

hemoglobin≥70g/L, platelets ≥50×10^9 / L, neutrophils ≥1.0×10^9/L

Kidney function

Creatinine clearance rate (estimated by Cockcroft-Gault formula)≥40mL/min

Liver function

Total bilirubin≤2×ULN; ALT ≤2.5×ULN and AST≤2.5×ULN

Cardiac function

Left ventricular ejection fraction >50%

Liver, kidney and cardiopulmonary functions meet the following requirements: 1. Creatinine clearance rate (estimated by CockcroftGault formula)≥40mL/min; 2. Total bilirubin≤2×ULN; Alanine aminotransferase (ALT) ≤2.5×ULN and aspartate aminotransferase (AST)≤2.5×ULN; 3. Left ventricular ejection fraction >50%; 4. Baseline peripheral oxygen saturation>95%

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

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