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.
Treatment: Human BCMA Targeted T Cells — A 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
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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