Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
Start Date
3/13/2025
Completion Date
5/24/2030
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)
Detailed 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 Criteria
Age Range: 18 years to 75 years
Interventions
Rapcabtagene autoleucel
Active Comparator
Glucocorticoids
Conditions
Locations
University Of Colorado
Aurora, Colorado 80045
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Northwestern University
Chicago, Illinois 60611
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Michigan Med University of Michigan
Ann Arbor, Michigan 48109 5271
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
Oregon Health Sciences University
Portland, Oregon 97239
United States
Baylor University Medical Center
Dallas, Texas 75246
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
LDS Hospital
Salt Lake City, Utah 84143
United States
Novartis Investigative Site
Salvador, Estado de Bahia 41253-190
Brazil
Novartis Investigative Site
Barretos, São Paulo 14784 400
Brazil
Novartis Investigative Site
São Paulo, São Paulo 01308-050
Brazil
Novartis Investigative Site
São Paulo, 01509-010
Brazil
Novartis Investigative Site
Haifa, 3109601
Israel
Novartis Investigative Site
Ramat Gan, 5265601
Israel
Novartis Investigative Site
Sapporo, Hokkaido 060-8648
Japan
Novartis Investigative Site
Kobe, Hyōgo 6500047
Japan
Novartis Investigative Site
Sendai, Miyagi 9808574
Japan
Novartis Investigative Site
Suita, Osaka 565-0871
Japan
Novartis Investigative Site
Bunkyo Ku, Tokyo 1138431
Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo 1608582
Japan
Novartis Investigative Site
Chiba, 2608677
Japan
Novartis Investigative Site
Fukuoka, 8128582
Japan
Novartis Investigative Site
Ishikawa, 9208641
Japan
Novartis Investigative Site
Kyoto, 6068507
Japan
Novartis Investigative Site
Riyadh, 11211
Saudi Arabia
Novartis Investigative Site
Singapore, 119074
Singapore
Novartis Investigative Site
Singapore, S308433
Singapore
Novartis Investigative Site
Basel, 4031
Switzerland
Novartis Investigative Site
Bern, 3010
Switzerland
Novartis Investigative Site
Cambridge, CB2 0QQ
United Kingdom
Novartis Investigative Site
London, W12 0HS
United Kingdom
Novartis Investigative Site
Manchester, M13 9WL
United Kingdom