eligibility_summary
Adults 18–70 with CD19+ acute B‑ALL (2022 WHO) in hematologic CR but MRD+ by flow after induction/intensified chemo, ECOG 0–2, adequate organs (CrCl ≥60, AST/ALT ≤3×ULN, TBil ≤2×ULN, LVEF ≥50%), life expectancy >8 wks, contraception/consent. Exclude: not in CR/extramedullary, prior HSCT, chemo <2 wks, prior blinatumomab, CNS leukemia, active autoimmune, major CV/COPD, severe infection/diabetes, thrombosis, uncontrolled HIV/HBV/HCV, pregnancy/lactation, severe mAb allergy, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm, multicenter Phase 1 in adults with MRD-positive CD19+ B-ALL undergoing haploidentical HSCT. Intervention: Blinatumomab (biologic, bispecific T-cell engager/BiTE antibody construct) given in conditioning (28 µg IV daily ×7 days) followed by routine conditioning and haploidentical allogeneic HSCT. Mechanism of action: Blinatumomab simultaneously binds CD19 on B-ALL cells and CD3 on T cells, redirecting cytotoxic T cells to form an immune synapse and kill CD19+ leukemic cells, aiming to clear MRD pre-transplant. HSCT adds graft-versus-leukemia via donor immune reconstitution. Targets/cells/pathways: CD19+ B-lymphoblasts, CD3/TCR on T cells, cytotoxic granule/apoptosis pathways, graft-versus-leukemia immune effect. Endpoints: PFS, OS, relapse, NRM, MRD, GVHD.