eligibility_summary
Eligibility: CD19+ B-ALL lacking suitable donor or refusing allogeneic HSCT, age 15–65, LVEF ≥50%, creatinine ≤1.6 mg/dL, ALT/AST ≤3×ULN, bilirubin ≤2.0 mg/dL, O2 sat >91% with ≤grade 1 dyspnea, T‑cell amplification passed, expected survival >3 months. Exclude: isolated extramedullary relapse, other malignancy, prior anti‑CD19, recent/planned immunosuppression, uncontrolled infection, HIV, active HBV/HCV, aminoglycoside reaction, major CNS disease.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06507514 tests a “sandwich” consolidation in CD19+ B‑ALL: blinatumomab → autologous HSCT → maintenance blinatumomab. Blinatumomab is a bispecific T‑cell engager (BiTE) antibody construct that links CD3 on T cells to CD19 on B‑ALL cells to drive T‑cell–mediated cytotoxicity and MRD clearance. Auto‑HSCT (cellular therapy) provides high‑dose chemotherapy consolidation with hematopoietic rescue while lowering transplant‑related mortality versus allo‑HSCT. Preceding therapy includes standard induction and consolidation with: cytarabine (antimetabolite nucleoside analog inhibiting DNA synthesis), methotrexate (antifolate DHFR inhibitor), pegaspargase (asparagine‑depleting enzyme), and optional TKIs (small‑molecule BCR‑ABL1 inhibitors in Ph+ disease). Targets/pathways: CD19+ B‑ALL blasts, T‑cell CD3 activation, DNA synthesis, folate metabolism, asparagine depletion, BCR‑ABL signaling, and hematopoietic stem cell reconstitution. Primary focus: safety/efficacy, MRD, LFS/OS/NRM.