eligibility_summary
Inclusion: R/R B-ALL (NCCN) or high-risk CD19/CD22+ with MRD >3 mo, CD19/CD22 >80% on blasts, age 1–70, ECOG 0–2, life expectancy ≥60 d, consent, no severe allergy. Exclusion: CNS hypertension/unconscious, cardiac/resp failure or arrhythmia, other malignancy, DIC, Cr/BUN >1.5×ULN, sepsis or uncontrolled infection incl HBV/HCV/HIV/TP, uncontrolled diabetes, severe psych, cranial MRI lesion, CSF blasts >20/µL, peripheral blasts >30%, organ recipient, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06343090 tests CAR T-cell strategies for r/r B-ALL. Interventions: (1) Sequential CAR therapy: murine-derived anti-CD19 CAR T cells followed by humanized anti-CD22 CAR T cells (autologous, genetically engineered T-cell therapy). (2) Single CD19 CAR T bridging to allogeneic hematopoietic stem-cell transplantation (allo-HSCT). Optional: single CD19 CAR T without consolidation. Mechanisms: CAR T cells redirect patient T cells to CD19 or CD22 on B cells, triggering CAR-mediated activation (CD3ζ-based signaling), cytokine release, and cytotoxic killing of leukemia cells, dual targeting aims to prevent antigen-loss escape. HSCT provides marrow reconstitution and graft-versus-leukemia immune effect. Targets: CD19+ and CD22+ B-ALL blasts and the B-cell lineage (B-cell aplasia). Pathways: B-cell antigen recognition and T-cell effector pathways leading to leukemia cell apoptosis.