eligibility_summary
Adults >18 with PET+ relapsed aggressive B‑cell NHL (DLBCL/HGBL/FL3B, transformed indolent post‑R‑CHOP allowed) relapsing 12 mo–5 yrs after full‑dose anti‑CD20+CHOP‑like 1st line. Must be CAR‑T eligible (ECOG 0–2, adequate counts/organ function). Exclude >1 prior line, early/refractory relapse, PMBCL, prior CD19 therapy, active CNS disease, cardiac involvement, urgent mass/effusion, infection/other cancer, immunodef/autoimmune, pulmonary disease, recent live vaccine, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial testing axicabtagene ciloleucel (axi-cel), an autologous, genetically engineered anti-CD19 CAR T-cell therapy, in adults with late-relapse aggressive B-cell lymphoma (DLBCL/HGBL/FL3B) after one prior R-CHOP–like regimen. Intervention: a single infusion of CAR-positive viable T cells (target 2×10^6/kg, max 2×10^8). Mechanism: patient T cells are modified to express a CD19-specific chimeric antigen receptor with CD28 costimulatory and CD3ζ signaling domains, CAR engagement activates T-cell cytotoxicity, proliferation, and cytokine release. Targets: CD19 on malignant (and normal) B cells, engages T-cell effector pathways (immune synapse, perforin/granzyme) leading to depletion of CD19+ lymphoma cells.