eligibility_summary
Include: CD19+/CD22+ relapsed/refractory B‑ALL or B‑cell lymphoma. ALL: early relapse (<6 mo), primary refractory (no CR after 2 cycles), relapse after salvage, or HSCT‑ineligible/relapsed. Lymphoma: poor response after ≥4 cycles, relapse ≤6 mo, ≥2 relapses, or HSCT‑ineligible/relapsed, prior anti‑CD20 + anthracycline. Also ECOG 0–2, >3‑mo survival, adequate organs (Hgb≥70, Cr/Tbili ≤1.5×ULN, ALT/AST ≤2.5×ULN, LVEF>50%, SpO2>90%). Exclude: major heart/lung disease, other advanced cancer, uncontrolled infection, severe auto/immune deficiency, active HBV/HCV, HIV/syphilis, severe biologic allergy, acute GVHD, or other high risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19 & CD22 bispecific CAR T cells—genetically engineered T‑cell immunotherapy. A single CAR with tandem scFv domains binds either CD19 or CD22 and includes a 4‑1BB co‑stimulatory domain, infused IV at 1–2×10^6 CAR‑T/kg (day 0). Mechanism of action: CAR engagement of CD19 or CD22 on malignant B cells activates T‑cell cytotoxicity, 4‑1BB enhances activation, proliferation, and persistence. Dual targeting is designed to limit antigen‑loss escape seen with single‑antigen CARs. Targets: B‑cell lineage antigens CD19 and CD22 on relapsed/refractory B‑cell leukemias/lymphomas (including B‑ALL). Trial: Phase 1/2, open‑label, single‑arm, multi‑center study assessing safety, efficacy, and CAR‑T PK/PD.