eligibility_summary
Eligible: R/R CD19+ B-ALL, age 3–70, BM blasts >=5% or MRD>1%, qualifies via >=2 relapses, chemo-refractory, post-HSCT >6 mo, or primary refractory. Ph+ must have failed/intolerant to >=1 TKI (T315I may skip). ECOG 0–1 or Lansky>50, survival >=3 mo, adequate counts/organs, consent/contraception. Exclude: isolated EM or active CNS disease, GVHD on IS, prior CAR-T/gene therapy, major cardiac/VTE, autoimmune on IS, serious infections, pregnancy, other cancers, marrow-failure syndromes, recent conflicting meds/vaccines/trials, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: INS19 CAR‑T cells (autologous chimeric antigen receptor T‑cell therapy) given after lymphodepletion with fludarabine and cyclophosphamide. Mechanisms: patient T cells are engineered to express a CAR that binds CD19 on B‑lineage cells, CAR engagement activates T‑cell signaling (CD3ζ with costimulatory domains), driving proliferation, cytokine release, and cytotoxic killing of CD19+ leukemic blasts, with expected on‑target B‑cell aplasia. Preconditioning drugs: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) deplete lymphocytes to enhance CAR‑T expansion and persistence. Cells/pathways targeted: CD19 antigen on malignant B‑ALL cells, adaptive immune effector pathways via CAR‑mediated T‑cell activation, reduction of regulatory/competing lymphocytes via lymphodepletion.