eligibility_summary
Adults (>=18) with histologically confirmed DLBCL at Moffitt, eligible for axicabtagene ciloleucel CAR-T, ECOG 0-2, ferritin >400 and CRP >2, transplant-ineligible due to active lymphoma, able to consent, contraception required. Exclude prior CAR-T, recent investigational agents, significant cardiac disease/unstable arrhythmias, active infections, HIV, HBV/HCV unless treated/suppressed, CNS autoimmune disease, chronic steroids, itacitinib allergy, unresolved >G1 AEs, pregnancy, cant swallow, strong CYP3A4 inhibitors.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05757219 tests pre-modulation with itacitinib plus standard axicabtagene ciloleucel (axi-cel) CAR T therapy in DLBCL patients with high systemic inflammation. Interventions: 1) Itacitinib—an oral small‑molecule, selective JAK1 inhibitor—given daily from post-apheresis through Day 30 post–CAR T. Mechanism: blocks JAK1–STAT signaling downstream of multiple pro‑inflammatory cytokines (e.g., IL‑6, IFN‑γ, IL‑2 family), aiming to dampen inflammation and improve CAR T outcomes. 2) Axi‑cel—autologous anti‑CD19 CAR T cells. Mechanism: CAR‑mediated recognition of CD19 on malignant B cells, T‑cell activation, and cytotoxic killing. Targets/pathways: CD19+ B cells, JAK‑STAT cytokine signaling in immune cells.