eligibility_summary
Adults ≥18 with MM or PCL, expected survival >12 wks, measurable disease (per IMWG: M‑protein, FLC ≥100 mg/L with abnormal ratio, or ≥10% clonal BM), and relapsed/refractory after ≥3 regimens incl a PI and an IMiD, with progression ≤60 days or <MR. Need CrCl ≥30, LVEF >50%, SpO2 >95%, bili ≤2×ULN, AST/ALT ≤2.5×ULN, Hb ≥60 g/L, ANC ≥1.0, Plt ≥30. Exclude: other malignancy, active HBV/HCV/HIV/syphilis, unstable disease, pregnancy, prior gene/CAR‑NK, severe allergy, infection, serious autoimmune, CNS sx, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Human BCMA-targeted CAR-NK cells (allogeneic, genetically modified natural killer cell therapy). Mechanism: NK cells are transduced with an anti-BCMA chimeric antigen receptor to recognize BCMA (TNFRSF17) on malignant plasma cells, activating NK effector functions (perforin/granzyme-mediated cytotoxicity and cytokine release) to kill tumor cells. Dosing: two infusions (Day 0 and Day 7) at 1.5×10^8, 3.0×10^8, or 6.0×10^8 CAR+ NK cells after preconditioning chemotherapy. Targets/pathways: BCMA on myeloma/plasma leukemia cells, NK-cell activation pathways, induction of tumor cell apoptosis. Population: adults with relapsed/refractory multiple myeloma or plasma cell leukemia. Design: single-arm, dose-escalation early phase 1 assessing safety, tolerability, PK/PD, and preliminary efficacy.