eligibility_summary
Eligible: CD19+ relapsed/refractory B‑cell lymphoma or B‑ALL, age 15–79, KPS≥50/ECOG≤2, >3‑mo survival, therapy washout, adequate counts/organ function (EF≥45%), no CNS disease, not pregnant. Exclude: WBC≥50 or rapid progression, active infection, HIV/HBV/HCV, CNS disorders, recent major cardiac events, anticoagulation/coagulopathy, systemic steroids, other active cancer, biologic allergy, poor T‑cell manufacture, conflicting meds/other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06596057 tests CD19-directed CAR-T and CAR-NK cells in relapsed/refractory CD19+ B‑cell lymphoma and B‑ALL. Type: biological, gene‑modified cellular immunotherapies (CAR-redirected T and NK cells, T cells are transduced ex vivo, typically via replication‑deficient lentivirus). Dosing: single IV infusion (~1–2×10^6 cells/kg) after fludarabine/cyclophosphamide lymphodepletion. Mechanism: the CAR binds CD19 on malignant B cells and signals via CD3ζ plus costimulatory domains to activate cytotoxic effector functions (perforin/granzyme release and cytokine secretion), CAR‑NK similarly engages NK killing pathways. Targets: CD19 on B‑lineage tumor cells, engages adaptive T cells and innate NK cells. Pathways modulated: CAR activation signaling, immune cytotoxicity, and lymphodepletion to promote in vivo expansion/persistence. Early Phase 1, single‑group safety/efficacy.