eligibility_summary
Adults (>=18) with NHL eligible for CD19 CAR-T, measurable disease/marrow, labs: WBC >=1.0, Hgb >=8, Plt >=50 x10^9/L, Cr <=2xULN, bili <=2xULN (Gilbert OK), AST/ALT <=3xULN, HBV suppressed, HCV undetectable, neg pregnancy test/contraception, consent. Exclude: steroid use >10 mg or prophylaxis, active CNS disease, HIV, pregnant/lactating, major uncontrolled illness. Siltuximab for >=G2 CRS or G1 ICANS >12h, 2nd dose if no change, not if steroids needed for CRS alone or prior DLT.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05665725 (Phase I, single-arm). Intervention: Siltuximab (Sylvant), a chimeric murine/human monoclonal antibody (biologic) that binds and neutralizes IL-6 ligand, promoting its clearance and blocking IL-6/IL-6R/gp130–JAK/STAT3 signaling to blunt hyperinflammation. Use: Given prophylactically before CD19 CAR T-cell therapy and as first-line treatment for grade ≥2 CRS (with option for a second dose). Targets: IL-6–driven inflammatory pathway underlying CRS and ICANS, downstream cytokine cascade. Disease/cells: CD19+ B-cell non-Hodgkin lymphoma treated with CD19-directed CAR T cells (T lymphocytes targeting CD19 on malignant B cells). Exploratory: CAR T expansion/persistence, plasma cytokines, peripheral immune phenotypes, and complement activation in ICANS. Imaging and blood collection included.