About this trial
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Eligibility criteria
Qualifiers
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
Positive test for ANCA-autoantibodies
GPA and MPA participants with severe active disease
Disqualifiers
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
Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol
Other systemic autoimmune diseases requiring therapy
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
Trial design
Treatments tested in this trial
- Rapcabtagene autoleucel
- Active Comparator
- Glucocorticoids