eligibility_summary
Eligibility: Age 16-70, ECOG 0-1, newly diagnosed CD19+ B-ALL (Ph- MRD>=0.01% by flow, or Ph+ MRD>=0.01% by flow or BCR-ABL1>0.01% by qPCR) in CR1, adequate organ function, meets leukapheresis criteria, consents. Exclude: prior CAR-T, marrow failure, active autoimmune, active infections incl HBV/HCV/HIV/EBV/CMV/syphilis, recent malignancy, major cardiac/CNS disease, uncontrolled diabetes, recent DVT/PE, hypersensitivity, recent live vaccine, life expectancy<3 mo, other trials, unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Inaticabtagene autoleucel (Inati‑cel, CNCT19), an autologous, gene‑modified CD19‑directed CAR‑T cell therapy (biologic, adoptive cellular immunotherapy). Dosing: single IV infusion of 0.2–0.6×10^8 CAR‑T cells after lymphodepletion, with an optional second infusion at 5–6 months to prolong persistence. Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor with an anti‑CD19 binding domain linked to intracellular activation motifs (CD3ζ with costimulation). CD19 engagement triggers T‑cell activation, proliferation, cytokine release, and cytotoxic killing of targets, aiming to clear minimal residual disease and induce durable B‑cell aplasia. Targets: CD19+ B‑ALL leukemic blasts and normal CD19+ B cells, pathways engaged include CAR signaling and adaptive T‑cell cytotoxic effector functions.