eligibility_summary
Eligibility: Adults 18–75 with CD123+ relapsed/refractory AML or BPDCN (failed/intolerant of prior therapy), expected survival >12 wks, ECOG 0–2, adequate organ function, no severe mental illness, consent. Exclude: recent anticancer therapy, stroke/seizure ≤6 mo, active infection, significant heart disease, active hepatitis B, active autoimmune disease needing immunosuppression, other malignancy (few exceptions), live vaccine <4 wks, pregnancy/breastfeeding or plans ≤1 yr, or investigator concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06006403 tests CD123-targeted CAR-NK cells for relapsed/refractory AML or BPDCN. Intervention: engineered natural killer cell therapy (cellular immunotherapy) given IV at 1–10×10^6 cells/kg after lymphodepleting conditioning with fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to enhance CAR-NK expansion. Mechanism: CAR redirects NK cells to CD123 (IL-3 receptor α) on malignant blasts/plasmacytoid dendritic cells, triggering NK cytotoxicity (CAR signaling, perforin/granzyme release, cytokines) to eliminate CD123+ tumor and stem-like leukemic cells. Targets: CD123-expressing AML and BPDCN cells, pathway focus is IL-3R/CD123 and activation of innate immune effector pathways. Phase 1/2, dose-escalation/expansion.