OncoMatch/Clinical Trials/NCT06045091
To Evaluate the Safety and Efficacy of Human BCMA Targeted CAR-NK Cells Injection for Subjects With R/R MM or PCL
Is NCT06045091 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Human BCMA targeted CAR-NK cells for multiple myeloma.
Treatment: Human BCMA targeted CAR-NK cells — This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of human BCMA targeted CAR-NK Cells injection, and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma or plasma cell leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Prior therapy
Must have received: proteasome inhibitor
Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory
Must have received: immunomodulatory
Patients have received at least 3 prior MM or PCL treatment regimens containing at least one proteasome inhibitor and one immunomodulatory
Cannot have received: CAR-NK therapy
Received CAR-NK treatment or other gene therapies before enrollment
Cannot have received: gene therapy
Received CAR-NK treatment or other gene therapies before enrollment
Lab requirements
Blood counts
hemoglobin ≥60 g/L, neutrophils ≥ 1.0×10^9/L, and platelets ≥30×10^9/L
Kidney function
Creatinine clearance rate (estimated by Cockcroft-Gault formula) ≥30mL/min
Liver function
Total bilirubin ≤ 2×ULN; ALT and AST ≤ 2.5×ULN
Cardiac function
Left ventricular ejection fraction > 50%; Baseline peripheral oxygen saturation > 95%
Liver, kidney and cardiopulmonary functions meet the following requirements: Creatinine clearance rate (estimated by CockcroftGault formula) ≥30mL/min; Left ventricular ejection fraction > 50%; Baseline peripheral oxygen saturation > 95%; Total bilirubin≤ 2×ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; Blood routine examination satisfying hemoglobin≥60 g/L, neutrophils≥ 1.0×10^9/L, and platelets≥30×10^9/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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