eligibility_summary
Inclusion: consent, CD19+ and/or CD22+ ALL/LLy (Cohort A relapsed/refractory, Cohort B poor response to prior B-cell engineered therapy), CNS3 allowed if responsive, antigen expression confirmed (post prior therapy if relapsed), age 0–29, adequate organs, PS ≥50, contraception. Exclusion: active HBV/HCV, HIV, active GVHD needing systemic therapy, steroids/immunosupp at collection/infusion, progressive CNS disease, pregnant/nursing, uncontrolled infection.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: CART22-65s and huCART19—both autologous, humanized CAR T-cell therapies (biologics). Each uses a humanized scFv against CD22 or CD19, respectively, linked to an intracellular CD3ζ signaling module plus 4‑1BB costimulatory domain. Mechanism: patient T cells are engineered to recognize CD22 or CD19 on B‑ALL/LLy cells, then activate via CD3ζ and co‑stimulate via 4‑1BB to expand, persist, and kill malignant B cells. Co‑administration seeks to (1) overcome CD19 antigen escape with anti‑CD22 CAR T and (2) reduce immune rejection/improve persistence with humanized anti‑CD19 CAR T. Targets/pathways: CD19+ and/or CD22+ B‑lineage blasts, T‑cell activation/survival via 4‑1BB.