eligibility_summary
Inclusion: age 3–18 with relapsed/refractory B‑ALL/lymphoblastic lymphoma (MRD>1% or inadequate response/relapse incl post‑transplant, marrow or extramedullary), Lansky ≥60, CD19/20/22+, survival >3 mo, Hb ≥70 g/L, Cr ≤1.5×ULN, LVEF ≥50%, SpO2 >90%, bilirubin ≤1.5×ULN, ALT/AST ≤2.5×ULN. Exclusion: severe cardiac/pulmonary disease, advanced malignancy, uncontrolled infection, severe auto/immune deficiency, active HBV/HCV, HIV/syphilis, severe biologic allergy, active post‑allo HSCT GvHD, or other serious risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase II, single-arm pediatric study in China testing BIC-19GG, BIC-2019, and BIC-2219—autologous CD19-directed CAR T-cell therapies—delivered by intravenous autotransfusion for relapsed/refractory CD19+ B-ALL/B-lymphoblastic lymphoma. Type of drug: adoptive cellular immunotherapy using genetically engineered autologous T lymphocytes. Mechanism of action: patient T cells are modified to express a chimeric antigen receptor that binds CD19, engagement activates CAR/TCR signaling (CD3ζ with costimulatory domains), leading to T-cell proliferation and targeted cytotoxicity (perforin/granzyme), elimination of malignant B cells, and expected on-target B-cell aplasia. Targets: CD19-expressing precursor B cells and associated CAR-activated T-cell pathways.