eligibility_summary
Eligible: adults 18-80 with >3 months life expectancy, active BCMA+ multiple myeloma, relapsed/refractory after ≥2 prior lines incl PI and IMiD, measurable disease per IMWG (M-protein or abnormal FLC ratio), ECOG 0-1, adequate cardiac/liver/renal function, consent. Exclude: pregnancy/lactation, active infections incl HIV, syphilis, HBV/HCV, recent steroids/immunosuppressants, severe organ failure or uncontrolled diabetes, other trial in past 3 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti-BCMA CAR-NK cells (biological, gene-modified cellular immunotherapy). Patients receive lymphodepletion with fludarabine and cyclophosphamide, then a single infusion of CAR-NK at escalating doses (1×10^7–1×10^8/kg). Mechanism of action: Natural killer cells are engineered with a chimeric antigen receptor to recognize BCMA (TNFRSF17) on myeloma cells, CAR engagement activates NK cytotoxic pathways (perforin/granzyme release and cytokine-mediated killing), aiming for potent antitumor activity with potentially fewer immune toxicities than CAR-T. Targets: BCMA-expressing malignant plasma cells, activation of NK signaling pathways. Primary goal: safety and MTD, efficacy by IMWG responses.