eligibility_summary
Includes adults 18–70 with untreated CD19+ large B‑cell lymphoma, ECOG 0–1, expected survival ≥12 weeks, adequate marrow/organ function, no CNS lymphoma, negative pregnancy test if applicable, consent required. Excludes allergy to product, prior stem/organ transplant, active infection/CNS disorders, prior modified T‑cell or anti‑CD19/CD3 therapy, other malignancies, prior checkpoint therapy, recent growth factors/stimulants, live vaccine <3 months.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Axicabtagene ciloleucel (axi-cel), an autologous anti‑CD19 chimeric antigen receptor (CAR) T‑cell therapy, given once at 2.0×10^6 CAR+ cells/kg as consolidation after first-line therapy in high‑risk large B‑cell lymphoma. Mechanism of action: Patient T cells are genetically engineered (typically via retroviral vector) to express a CAR containing a CD19‑binding scFv with CD28 costimulatory and CD3ζ signaling domains. Upon CD19 engagement, CAR T cells activate, expand, and kill malignant B cells through perforin/granzyme release and cytokine-mediated cytotoxicity, on‑target effects include B‑cell aplasia, risks include CRS/ICANS. Targets: CD19 antigen on malignant B cells, T‑cell activation/costimulatory pathways (CD28/CD3ζ) and downstream immune effector pathways.