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
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)
Description
This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts: * A lead-in cohort enrolling participants to receive rapcabtagene autoleucel * A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator. After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalRapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel
- OtherActive Comparator
Active comparator option as per protocol
- DrugGlucocorticoids
Concomitant glucocorticoids as per protocol
Locations (31)
- University Of ColoradoAurora, Colorado
- Mayo Clinic JacksonvilleJacksonville, Florida
- Northwestern UniversityChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Mayo Clinic RochesterRochester, Minnesota
- Oregon Health Sciences UniversityPortland, Oregon