Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
A Phase 2, Randomized, Open-label, Controlled Study to Evaluate the Efficacy and Safety of Rapcabtagene Autoleucel Versus Comparator in Participants With Severe Active Granulomatosis With Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
Novartis Pharmaceuticals
126 participants
Mar 13, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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
Exclusion Criteria5
- 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
- Inadequate organ function
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Interventions
Single infusion of rapcabtagene autoleucel
Active comparator option as per protocol
Concomitant glucocorticoids as per protocol
Locations(31)
View Full Details on ClinicalTrials.gov
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NCT06868290