Study Description
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) 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.
Interventions
Active Comparator
Glucocorticoids
Rapcabtagene autoleucel
Eligibility Criteria
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
Novartis Investigative Site
Recruiting
São Paulo,01509-010,Brazil
Novartis Investigative Site
Recruiting
Haifa,3109601,Israel
Novartis Investigative Site
Recruiting
Ramat Gan,5265601,Israel
Novartis Investigative Site
Recruiting
Chiba,2608677,Japan
Novartis Investigative Site
Recruiting
Sendai,Miyagi,980 8574,Japan
Novartis Investigative Site
Recruiting
Suita,Osaka,565 0871,Japan
Novartis Investigative Site
Recruiting
Kyoto,606 8507,Japan
Novartis Investigative Site
Recruiting
Kanazawa,Ishikawa-ken,920 8641,Japan
Novartis Investigative Site
Recruiting
Kobe,Hyōgo,650-0047,Japan
Novartis Investigative Site
Recruiting
Sapporo,Hokkaido,060 8648,Japan
Novartis Investigative Site
Recruiting
Riyadh,11211,Saudi Arabia
Novartis Investigative Site
Recruiting
Singapore,119074,Singapore
Novartis Investigative Site
Recruiting
Singapore,S308433,Singapore
Novartis Investigative Site
Recruiting
Bern,3010,Switzerland
Novartis Investigative Site
Recruiting
Basel,4031,Switzerland
Novartis Investigative Site
Recruiting
Cambridge,Cb2 0qq,United Kingdom
Northwestern University
Recruiting
Chicago,Illinois,60611,United States
Anisha Dua
John Seagrist
Oregon Health Sciences University
Recruiting
Portland,Oregon,97239,United States
Atul Deodhar
Chloe Reiter
Houston Methodist Hospital
Recruiting
Houston,Texas,77030,United States
Sarah Kazzaz
Alice Quach
Mayo Clinic Rochester
Recruiting
Rochester,Minnesota,55905,United States
Ulrich Specks
Massachusetts General Hospital
Recruiting
Boston,Massachusetts,02114,United States
John Stone
LDS Hospital
Recruiting
Salt Lake City,Utah,84143,United States
Catherine Jennifer Bakewell
Mayo Clinic Jacksonville
Recruiting
Jacksonville,Florida,32224,United States
Vikas Majithia
University Of Colorado
Recruiting
Aurora,Colorado,80045,United States
Larry Moreland
Worldwide Contacts
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