eligibility_summary
Adults 18–65 with CD19+ refractory/relapsed B‑ALL, large B‑cell lymphoma (DLBCL, transformed FL, PMBCL) or MCL after ≥2 lines, ECOG ≤1, weight 40–130 kg, adequate heart/liver/kidney/lung function, negative HBV/HCV/HIV/syphilis, contraception and negative pregnancy test, survival ≥12 mo, COVID‑19 vaccine ≥6 mo prior, Polish fluent, consent. Exclude CNS disease, bulky/rapid disease, <3 mo post allo‑HSCT/DLI, recent high‑dose chemo, other cancers, active/latent infection, key drug allergy/intolerance, systemic immunosuppression/GvHD therapy, lack of vaccine/consent, non‑Polish, prior anti‑CD19 CAR‑T.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: FCTX-CL19-1 (Tarcidomgen Kimleucel), an autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, classified as a biological Advanced Therapy Medicinal Product (ATMP) and Gene Therapy Medicinal Product (GTMP). Single IV infusion at 0.2–2.0 ×10^6 CAR T cells/kg. Mechanism of action: patient T cells are genetically modified to express a CAR that binds CD19, engagement triggers CAR signaling, activating and expanding T cells to kill targets via cytotoxic granules and cytokines, leading to depletion of CD19+ B cells and tumor clearance. Targets: CD19 antigen on B-lineage cells in B-ALL, large B-cell lymphoma (incl. DLBCL/PMBCL/transformed FL), and mantle cell lymphoma.