eligibility_summary
Eligible: CD19+ ALL, age ≥3, life expectancy >12 wks, ECOG 0–2 or KPS >60, women of childbearing potential: negative test + contraception through 2 wks post-infusion, adequate marrow/liver/renal function per protocol (labs within 7 d). Exclude: pregnancy/nursing, HIV/HBV/HCV, serious uncontrolled illness, allergy to cyclophosphamide/fludarabine/aldesleukin, systemic steroids, ulcers/GI bleed, need anticoag or high-dose antiplatelets, fludarabine/cladribine ≤3 mo pre‑leukapheresis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1/2 single-arm trial in relapsed/refractory CD19+ B-ALL testing anti-CD19 CAR-NK cells. Intervention: single infusion of genetically engineered natural killer cells expressing a CD19-specific chimeric antigen receptor (biologic cell therapy). Mechanism: CAR binding to CD19 on malignant B cells activates NK cytotoxic pathways (perforin/granzyme) and cytokine-mediated killing. Conditioning: fludarabine (antimetabolite purine analog) and cyclophosphamide (alkylating agent) for lymphodepletion to enhance CAR-NK expansion/persistence. Targets: CD19+ leukemic B cells, pathways: CD19 antigen recognition and NK activation signaling.