eligibility_summary
Eligible: adults 18–75 with relapsed/refractory CD19+ B‑cell lymphoma after ≥2 lines, measurable disease, ECOG 0–2, life expectancy ≥3 mo, adequate labs/organ function (Hb ≥8, ANC ≥1.0, platelets ≥75 or ≥50 with BM involvement, AST/ALT/bilirubin/creatinine within limits), LVEF ≥50%, contraception required. Exclude: major cardiac disease, severe lung disease, other malignancy, active infection, autoimmune/ID, HIV+, CNS disease, prior CAR‑T, recent/allo SCT, recent surgery/live vaccines, pregnancy, cardiac lymphoma, emergencies, noncompliance/unfit.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: L218CAR19, a chimeric antigen receptor T-cell (CAR‑T) therapy administered by IV infusion in a Phase 1 dose‑escalation study. Type: Cellular gene therapy (engineered T lymphocytes). Mechanism of action: Patient T cells are genetically modified to express a CAR that binds CD19 on B cells. Antigen engagement triggers CAR signaling (TCR‑independent activation via CD3ζ/co‑stimulatory domains), leading to T‑cell activation, proliferation, cytokine release, and cytolytic killing of CD19+ cells. Targets (cells/pathways): CD19-expressing malignant B cells in relapsed/refractory B‑cell lymphomas (and normal CD19+ B cells). Primary biological pathways engaged are CAR-mediated T‑cell activation and cytotoxic effector pathways against the B‑cell lineage. Study goal: assess safety, tolerability, PK/PD, and preliminary activity.