eligibility_summary
Inclusion: consent/assent, age >1 mo–<18, relapsed/refractory B‑ALL ≥5% marrow blasts (≥2nd relapse, post‑alloHSCT relapse, or refractory to induction/reinduction), PS ≥50. Exclusion: active/untreated CNS ALL or major CNS disease, isolated EM, other malignancy, Burkitt’s, renal/hepatic dysfunction, active infection, HIV/HBV/HCV, blinatumomab allergy, alloHSCT <12w or active GVHD, RT <2w, immunotx <4w (prior anti‑CD19 ok if >4w & CD19+), chemo <2w (except IT/low‑dose), other trials <4w, pregnant/breastfeeding/no contraception, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Blinatumomab (Blincyto), a bispecific T-cell engager (BiTE) antibody construct, given by continuous IV infusion (28 days on, 14 days off) for up to 5 cycles. Mechanism of action: Simultaneously binds CD19 on B-lineage leukemia cells and CD3 on T cells, redirecting endogenous T cells to CD19+ blasts to form an immune synapse and induce cytotoxic killing via perforin/granzyme release, activates and proliferates T cells and causes B-cell depletion. Targets: CD19-expressing B-precursor ALL cells and CD3 on T lymphocytes, leveraging TCR signaling and T cell–mediated cytotoxic pathways. Population: Chinese pediatric R/R B-ALL.