eligibility_summary
Eligible: 3–18 yrs (≥10 kg) with relapsed/refractory CD19+ ALL, ≥5% marrow blasts, KPS ≥70 (≥16 yrs) or Lansky ≥50 (<16 yrs), adequate renal/liver function, consent. Exclude: active CNS leukemia, isolated extramedullary relapse, Burkitt’s/MPAL/CML-BC, genetic syndromes, recent/mod-severe GVHD, active autoimmune disease, HIV/HBV/HCV or active infection, recent prohibited chemo/radiation (non‑CNS <4 wks, CNS <8 wks), DLI <6 wks, prior CAR‑T, life expectancy <3 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib/II single-arm pediatric study of CNCT19, an autologous, second‑generation CD19‑directed CAR‑T cell therapy (single IV infusion) given after lymphodepletion with fludarabine and cyclophosphamide. Mechanisms: CAR‑T—patient T cells are engineered to express a chimeric antigen receptor that binds CD19 on B‑cell precursors, CAR engagement triggers T‑cell activation (with integrated costimulation), proliferation, cytokine release, and cytotoxic killing of CD19+ leukemic cells, expected on‑target effect includes depletion of normal CD19+ B cells. Lymphodepletion—fludarabine (purine analog) and cyclophosphamide (alkylating agent) reduce host lymphocytes to enhance CAR‑T expansion and persistence. Targets: CD19 antigen on B‑precursor ALL blasts and normal B cells.