eligibility_summary
Adults (>=18) with newly diagnosed Ph/BCR-ABL1 negative CD19+ ALL, life expectancy >3 months, adequate organ function (bilirubin <=1.5x ULN, ALT/AST <=2.5x ULN or <=5x if liver involvement, creatinine <=1.5x ULN, amylase/lipase <=1.5x ULN, ALP <=2.5x ULN unless tumor, normal electrolytes, LVEF >=45%) and consent. Exclude Burkitt, ambiguous lineage, active CNS/extramedullary ALL, pregnant/lactating, infection, HIV+, major arrhythmias/AV block w/o pacer, serious psych illness, or other unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06481241: Single-arm trial in newly diagnosed adult Ph− B-ALL. Regimen: pediatric-inspired chemotherapy plus venetoclax to achieve CR, followed by consolidation with a single infusion of autologous CD19-directed CAR-T cells (murine-derived, second-generation with 4-1BB costimulation, dose ~1×10^6 CAR+ cells/kg). Interventions and mechanisms: 1) CAR-T cells—genetically engineered adoptive T-cell therapy, CAR binds CD19 on B-cell blasts, and 4-1BB signaling enhances T-cell activation, proliferation, persistence, and cytotoxic killing to eliminate residual disease. 2) Venetoclax—oral small-molecule BH3 mimetic, selective BCL-2 inhibitor that restores mitochondrial apoptosis, sensitizing leukemic cells. Targets/pathways: CD19+ B-ALL blasts, BCL-2 anti-apoptotic pathway, T-cell activation via 4-1BB.