eligibility_summary
Inclusion: age 1–25 w/ R/R B‑ALL, CD19/CD22+, KYMRIAH‑eligible, PS ≥50, adequate marrow/organ fxn (ANC ≥750, Plt ≥50k, ALC >150, O2 >92%, Cr nl/CrCl ≥60, bili ≤1.5, AST/ALT ≤10×ULN, EF ≥40%, cytopenias OK if disease‑related), CNS OK if asymptomatic, prior auto/allo SCT (≥100 d, no GVHD, off IS ≥30 d), prior CAR ≥30 d, washouts/recovery, contraception, neg pregnancy test. Exclusion: HIV/HBV/HCV, uncontrolled illness, blasts ≥50k, rapid progression, severe allergy, active CNS disorder, major cardiac dz <12 mo, primary immunodef or autoimmune needing IS ≤2 y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: 1) Tisagenlecleucel (KYMRIAH) – an FDA‑approved autologous anti‑CD19 CAR T‑cell therapy (4‑1BB costimulation). Mechanism: patient T cells are engineered to express a CAR recognizing CD19 on B cells, triggering T‑cell activation, cytotoxicity, and cytokine release, leading to malignant B‑cell clearance and B‑cell aplasia. 2) Autologous CD22 CAR T cells (investigational), infused 28–42 days after tisagenlecleucel, mechanism analogous, targeting CD22 to eliminate residual/antigen‑shifted B‑ALL. Lymphodepleting chemotherapy precedes infusions to enhance CAR T expansion. Targets/pathways: CD19+ and CD22+ B‑lineage cells, effects on B‑cell receptor–expressing malignant blasts, activation of T‑cell signaling via CAR (CD3ζ with costimulation). Population: children/young adults with R/R B‑ALL.