eligibility_summary
Eligible: Chinese children 1–18 yrs, ≥10 kg, consent, MRD+ day 46 post‑induction, CD19/CD22+ within 3 months, adequate organ function, KPS≥70 or Lansky≥50, survival ≥12 wks, venous access. Exclude: genetic diseases (except Down), other malignancy, HBV/HCV/HIV/syphilis/EBV/CMV+ or uncontrolled infection, recent G‑CSF, active CNS leukemia, allergy to albumin/aminoglycosides, prior organ transplant (not HSCT), recent trials, intolerant of chemo/CRS, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous, retroviral vector–engineered tandem (bispecific) CD19/CD22 CAR-T cells for pediatric MRD-positive B-ALL, preceded by lymphodepleting fludarabine + cyclophosphamide (cytotoxic chemotherapy) and followed by standard CCCG-ALL chemotherapy. Mechanism (type: adoptive cellular immunotherapy): patient T cells are modified to express a CAR that simultaneously binds CD19 and CD22 on B-lineage blasts, triggering T-cell activation (CD3ζ), costimulation, expansion, cytokine release, and perforin/granzyme-mediated cytotoxic killing, leading to MRD eradication and B-cell aplasia. Targets: surface antigens CD19 and CD22 on B-cell precursor leukemia, preconditioning reduces host lymphocytes to enhance CAR-T expansion.