eligibility_summary
Eligibility: Age 5–25, AAV (2022 EULAR/ACR) refractory/relapsed after ≥3 mo steroids + cyclophosphamide/rituximab ± ≥1 other immunosuppressant, or severe vasculitis judged to benefit, PVAS≥15 (<18) or BVAS≥15 (≥18), adequate organ function (LVEF≥55%, eGFR≥30, AST/ALT≤3×ULN, TBIL≤2×ULN, SpO2≥92%), eligible for leukapheresis, negative pregnancy test/contraception, consent. Exclude: prior CAR‑T, active CNS disease, prolonged pulmonary hemorrhage, major heart disease/instability, diseases needing long‑term steroids/high‑dose IS, uncontrolled/active infection, prior organ/HSCT or recent ≥G2 GVHD, active HBV/HCV/HIV/syphilis/CMV, live vaccine <4 wks, pregnancy, malignancy, other trial <3 mo, investigator deems unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests anti-CD19 CAR-T cells for refractory childhood-onset ANCA-associated vasculitis. Intervention: intravenous infusion of autologous, genetically engineered chimeric antigen receptor T cells targeting CD19 (cellular gene therapy/adoptive cell transfer). Mechanism of action: patient T cells are modified to express an anti-CD19 CAR, upon binding CD19, they activate and kill B-lineage cells, producing deep, sustained B‑cell depletion (including plasmablasts) and potential immune “reset.” Target cells/pathways: CD19+ B cells in blood/lymphoid tissues/bone marrow, suppression of ANCA-producing B cells and humoral autoimmunity, indirectly reducing neutrophil activation and small-vessel inflammatory pathways central to AAV pathogenesis.