eligibility_summary
Adults ≥18 with aggressive NHL (DLBCL, tFL, PMBCL, HGBL, FL3B). Prior therapy: ≥2 lines (C1/2/4) or 1 line (C3), incl anti‑CD20 + anthracycline, tFL treated post‑transformation, Cohort 5: high‑risk 1L. Must be relapsed/refractory, measurable disease, ECOG 0–1 (0–2 C5), ANC ≥1000, platelets ≥50k, ALC ≥200. Exclude: active CNS, other cancers <3y, cardiac/EBV+ lymphoma, recent therapy/radiation, unresolved tox, allo/solid transplant, recent ASCT, prior non‑FMC63 CAR, PID, significant autoimmune.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: LYL314, an autologous, gene‑modified CD19/CD20 dual‑targeting CAR T‑cell therapy (single IV infusion after conditioning), fludarabine and cyclophosphamide as lymphodepleting chemotherapy. Mechanisms: LYL314 T cells express a chimeric antigen receptor that binds CD19 and CD20 on malignant B cells, activating T‑cell signaling and cytotoxic killing (perforin/granzyme) leading to B‑cell aplasia. Fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) deplete host lymphocytes, reducing immunologic competition and enabling CAR T expansion. Targets: CD19/CD20‑positive B‑cell lymphoma cells, pathways: B‑cell surface antigens and T‑cell effector activation.