eligibility_summary
CAR‑T trial with two cohorts. B‑NHL: adults 18–70 with R/R DLBCL/HGBCL/double‑hit/FL3B/tFL after ≥2 lines incl anti‑CD20+anthracycline, ASCT done or ineligible, measurable disease, adequate organs. B‑ALL: age 3–<25, CD19+ R/R, ≥5% marrow blasts after chemo±HSCT/TKI, adequate organs. Exclude: other recent cancers, hematopoietic syndromes, prior CAR‑T/solid organ txp, CNS disease, serious infections, major comorbidities, recent surgery/live vaccines, pregnancy, life expectancy <12 wks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CART-19, an autologous, second-generation CD19-directed CAR-T cell therapy. Type: cellular gene therapy/immunotherapy. Construct: patient T lymphocytes transduced by lentiviral vector to express a CAR with anti-CD19 scFv, 4-1BB co-stimulatory domain, and CD3zeta signaling domain. Mechanism: CAR binding to CD19 activates T cells via CD3zeta with 4-1BB costimulation, driving expansion, cytokine release, and cytotoxic killing of CD19+ cells, expected on-target B-cell aplasia. Pre-infusion lymphodepletion: cyclophosphamide (alkylating agent) and fludarabine (purine analog) to deplete host lymphocytes and promote CAR-T engraftment/expansion. Targets: CD19 on malignant B cells in R/R B-ALL and B-cell NHL (DLBCL, HGBCL, FL3B, tFL). Key pathways/cells: B-cell CD19 surface antigen, T-cell activation and costimulation (CD3zeta/4-1BB).