eligibility_summary
Adults (>=18) with high-risk aggressive B-cell NHL (DLBCL/PMBCL/transformed FL or MZL/high-grade NOS), LDH>ULN near leukapheresis, exactly 1 prior line, measurable disease, ECOG 0-1 (2 if lymphoma-related), adequate organ function, O2>92%, consent, contraception, CD19+ if prior CD19 therapy, >=2-wk/5-half-life washout. Exclude prior CAR-T or allo-HSCT, active CNS lymphoma, steroid/RT-only bridging, Axi-Cel allergy, Richter’s, invasive cancer <5y (except NMSC/CIS), pregnancy/breastfeeding, stroke/TIA <12m, active seizures, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase Ib, open-label study evaluating axicabtagene ciloleucel reinfusion (Axi-Cel-2) in adults with high-risk relapsed/refractory large B-cell lymphoma after standard-of-care axi-cel. Intervention: autologous anti-CD19 chimeric antigen receptor T-cell therapy (CAR T, genetically engineered patient T cells). CAR design: CD19-specific scFv linked to CD28 costimulatory and CD3ζ activation domains. Safety run-in gives 0.5×10^6 CAR T cells/kg (25% dose) between days 7–14 if CRS/ICANS ≤ grade 1, Phase 1b uses target dose. Mechanism: CAR engagement of CD19 on malignant B cells activates T-cell signaling, expansion, cytokine release, and perforin/granzyme-mediated cytotoxicity, depleting CD19+ B cells. Targets: CD19 on B-cell lymphomas, pathways include CAR/TCR signaling via CD28/CD3ζ and downstream immune effector functions.