eligibility_summary
Adults 18–75 with CD123+ relapsed/refractory AML or BPDCN (failed/intolerant to salvage), survival >12 wks, ECOG 0–2, no severe mental illness, adequate organ function (hematologic, cardiac LVEF≥50%, renal, hepatic, SpO2>92%). Exclude: active CNS disease, anti-tumor therapy ≤14d, CVA/seizure ≤6mo, active infection ≤1wk, serious heart disease, autoimmune on immunosuppression, other malignancies (except low-risk), live vaccine ≤4 wks, pregnant/breastfeeding or planning ≤1yr.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti‑CD123 CAR‑NK cells (engineered cellular immunotherapy, chimeric antigen receptor natural killer cells). Mechanism of action: NK cells are genetically modified to express a CAR that binds CD123 (IL‑3 receptor alpha) on tumor cells, CAR engagement activates NK cytotoxicity (perforin/granzyme, death receptor pathways) to lyse CD123+ cells. Dosing: two infusions (Day 0, Day 7) at 1×10^7, 3×10^7, or 5×10^7 CAR+ cells/kg in a Phase 1, single‑arm dose‑finding study. Targets: CD123‑positive malignant cells—AML blasts, leukemic stem/progenitor cells, and BPDCN/plasmacytoid dendritic tumor cells. Pathway focus: surface antigen CD123 (IL‑3Rα) on myeloid and plasmacytoid dendritic lineages. Population: relapsed/refractory CD123+ AML or BPDCN.