eligibility_summary
Include: LBCL (DLBCL NOS or HGBL), transformed DLBCL from FL/MZL if no prior anthracycline, IPI 4–5, only 1 R‑chemo cycle, adequate organ function, negative pregnancy test. Exclude: T/HR LBCL, primary CNS DLBCL, PMBCL, BCLU w/ Hodgkin features, Burkitt, Richter’s, CNS/CSF disease, cardiac lymphoma, >1 prior therapy, severe hypersensitivity, stroke/TIA/PRES ≤12 mo, active HBV/HCV, HIV unless on therapy, undetectable, CD4>200, significant cardiac disease, immunosuppression ≤2 y, other protocol limits.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05605899 (ZUMA-23) is a Phase 3 trial in first-line high-risk LBCL comparing: 1) Axicabtagene ciloleucel (axi-cel, autologous anti‑CD19 CAR‑T cell therapy, biological/gene‑modified cell product) given after lymphodepletion with cyclophosphamide (alkylating agent) and fludarabine (purine analog/antimetabolite), versus 2) Standard chemoimmunotherapy: R‑CHOP or DA‑EPOCH‑R—rituximab (anti‑CD20 monoclonal antibody), doxorubicin (anthracycline/topo II inhibitor), etoposide (epipodophyllotoxin/topo II inhibitor), cyclophosphamide (alkylator), vincristine (vinca alkaloid/microtubule inhibitor), prednisone (corticosteroid). Targets/pathways: malignant CD19+/CD20+ B cells, T‑cell activation and cytotoxicity (CAR signaling), DNA replication/repair (topo II, alkylation), microtubules (mitotic arrest), glucocorticoid receptor, lymphodepletion reduces host lymphocytes to support CAR‑T expansion.