eligibility_summary
Eligible adults 18–65 with newly diagnosed high‑risk Ph‑ B‑ALL (WHO 2022), CD19+ and CD22+ leukemia, expected survival >12 weeks, consenting. Exclude: CNS injury/epilepsy/stroke, prolonged QT/severe cardiac disease, pregnancy/lactation, severe active infection, HIV, active HBV/HCV, prior CAR‑T/GM T cells, creatinine >2.5 mg/dL, ALT/AST >3× ULN, bilirubin >2.0 mg/dL, other uncontrolled disease or investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in adults with newly diagnosed high-risk Ph− B‑ALL. Interventions: (1) Azacitidine—hypomethylating cytidine analog (antimetabolite), induces DNA hypomethylation/epigenetic reprogramming and cytotoxicity. (2) Venetoclax—oral small‑molecule BCL‑2 inhibitor, triggers mitochondrial apoptosis in leukemic cells. (3) Bridging dual‑target CD19/CD22 CAR‑T—autologous gene‑modified T cells, CAR‑mediated recognition and killing of CD19+CD22+ B‑ALL blasts, dual targeting aims to reduce antigen escape. Targets/pathways: malignant B cells expressing CD19 and CD22, BCL‑2–dependent survival pathway, epigenetic dysregulation via DNA methylation, T‑cell–mediated cytotoxic pathways. MRD‑negative patients may proceed to HSCT. Primary focus: safety and efficacy.