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Anti-CD 19 CAR-T Cell Therapy in Patients With ANCA Vasculitis

David Simon · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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The goal of this phase I/II clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell (CAR-T cell) therapy in patients with antineutrophil cytoplasmic antibodies (ANCA) immunoglobulin (IgG) positive ANCA associated vasculitis (AAV). The main questions it aims to answer are: * To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory, ANCA-IgG-positive AAV * To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory ANCA-IgG-positive AAV * To assess the ANCA seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV Participants will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR-T cell immunotherapy. Follow-up time is 52 weeks with regular visits at the site.
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