eligibility_summary
Eligibility: <25 years with CD19+ B-ALL, in hematologic CR (<5% marrow blasts) after 1st/2nd-line. HSCT-eligible by ≥1: Ph+ t(9,22), hypodiploidy (<44 chr), E2A-HLF t(17,19), MRD ≥0.01% after consolidation/maintenance, first-line failure, or per investigator. Exclude: prior HSCT, inadequate leukapheresis, HIV, uncontrolled infection, pregnancy/breastfeeding, or other investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SNUH-CD19-CAR-T, an autologous, gene-modified cellular immunotherapy (CAR-T). Mechanism: patient peripheral blood T cells are engineered to express a chimeric antigen receptor whose scFv binds CD19 on B cells, enabling MHC-independent recognition, CAR engagement activates T-cell effector functions (cytotoxic killing and cytokine release) leading to depletion of CD19+ leukemic and normal B cells. Targets: CD19 antigen on B-cell acute lymphoblastic leukemia blasts and the broader CD19+ B-cell compartment, immune effector pathway is CAR-mediated T-cell activation. Setting: phase 2, single-group trial in pediatric/adolescent very-high-risk CD19+ B-ALL as an alternative to HSCT.