eligibility_summary
Adults ≥18 with CD19+ B‑ALL in CR with MRD after induction (BM <5% blasts), ECOG 0–1, adequate organ/hematologic function. Allowed: grade 1 neuropathy, steroid/asparaginase diabetes/HTN, therapy‑related cytopenias. Exclude: other leukemia subtypes, active infections incl HIV/HBV/HCV, major cardiac disease, CNS disease/leukemia, severe comorbidity/active cancer, immunodeficiency/autoimmune on recent immunosupp, recent thrombosis, live vaccine ≤4w, pregnancy/breastfeeding, contraception required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Tecartus (brexucabtagene autoleucel, KTE‑X19), an autologous, gene‑modified CAR T‑cell therapy. Mechanism: patient T cells are retrovirally engineered to express a CD19‑specific chimeric antigen receptor with CD28 costimulatory and CD3ζ signaling domains, upon CD19 binding, CAR T cells activate, expand, and kill targets via cytotoxic effector pathways. Targets: CD19+ B‑lineage lymphoblasts (MRD in B‑ALL) and normal CD19+ B cells. Pathways engaged: CAR‑mediated T‑cell activation (CD3ζ signaling) and co‑stimulation (CD28), leading to cytokine release and perforin/granzyme‑driven cytolysis, aiming to eradicate residual leukemic cells. Phase 2, single‑arm.