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This study evaluates a CD19 CAR-T cell therapy (Rapcabtagene autoleucel) compared with glucocorticoids in people with severe active GPA (granulomatosis with polyangiitis) or MPA (microscopic polyangiitis), forms of ANCA-associated vasculitis. Adults aged 18-75 with a positive ANCA test and severe active disease may take part. Sponsored by Novartis Pharmaceuticals, this Phase 2 study is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key inclusion criteria: 1. Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 (ACR/EULAR 2022) classification criteria 2. Positive test for ANCA-autoantibodies 3. GPA and MPA participants with severe active disease Key exclusion criteria: 1. Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study 2. Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol 3. Other systemic autoimmune diseases requiring therapy 4. Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy 5. Inadequate organ function