eligibility_summary
Adults 18–75 with r/r CD19+ B‑cell lymphoma (iNHL/FL/MZL, DLBCL/PMBCL/TFL/TCRBCL), measurable FDG+ disease, ECOG 0–1, ≥12‑wk survival, consent, organ/marrow OK (ANC>1000, Plt≥50k, Hb>8). Washouts: steroids 72h, immunosupp 4w, anti‑prolif 2w, anti‑CD20 4w/5 t½, CNS ppx 1w. Exclude CNS disease, recent trial drugs/radiation, prior anti‑CD19/CD3 or gene therapy, active HBV/HCV/HIV, infection, angina/MI, arrhythmia, anticoag ≤1w, neuroautoimmune, pregnancy, contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: JY231 injection — a biologic, autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. Patients receive lymphodepletion (fludarabine + cyclophosphamide) followed by JY231 via IV, intraperitoneal, or lymph-node infusion at escalating doses. Mechanism of action: Patient T cells are engineered to express a CAR that binds CD19 on B cells, triggering CD3ζ and costimulatory signaling to activate and expand T cells, induce cytokine release, and mediate cytotoxic killing (perforin/granzyme–mediated apoptosis). Targets: CD19+ malignant B cells in relapsed/refractory B-cell lymphomas (e.g., DLBCL, PMBCL, FL, MZL, TFL), anticipated on-target depletion of normal CD19+ B cells. Purpose: Evaluate safety, tolerability, and preliminary efficacy with serial monitoring in blood, bone marrow, and CSF. Status: Early Phase 1, single-arm, single-center.