eligibility_summary
Eligible: 3 mo–30 y with B‑precursor ALL in ≥2nd relapse, post‑allo BMT relapse, or R/R after single‑antigen CAR‑T (≥90 d since prior), refractory to SOC or decline BMT, CD19/CD22+, PS (Lansky/Karnofsky ≥50% or ECOG ≤2), apheresis feasible, consent, not pregnant/lactating, long‑term follow‑up. Exclude: uncontrolled CNS leukemia, recent/active allo‑SCT issues, serious infection, severe organ dysfunction, unwilling to use contraception, HIV or active HBV/HCV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06559189: Phase I trial in pediatric/young adult relapsed/refractory B-ALL testing CD19x22 CAR T cells. Intervention: autologous, genetically modified T-cell therapy (cellular gene therapy/immunotherapy) co-expressing a bispecific CAR recognizing CD19 and CD22. Mechanism of action: CAR-mediated binding to CD19/CD22 on B-lineage blasts activates T cells (via CAR signaling domains), inducing cytokine release and perforin/granzyme cytotoxic killing, dual targeting aims to reduce antigen-loss escape seen with single-antigen CARs. Targets: malignant B-cell precursors expressing CD19 and/or CD22, pathways/cell types include B-lineage surface antigens and T-cell activation/cytotoxic pathways. Design: BOIN dose escalation post-lymphodepletion in high- and low-burden cohorts (starting 1×10^5–3×10^5 cells/kg). Primary: safety/MTD, exploratory efficacy: remission/MRD.