Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Circulation Disorders
Lupus
Treatment
Active Comparator
Rapcabtagene autoleucel
Glucocorticoids
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key inclusion criteria:
Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according tothe 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
Key exclusion criteria:
Any condition that could prevent a complete washout of medications or couldotherwise make the participant ineligible for anti-CD19 CAR-T therapy and furtherparticipation in the study
Hypersensitivity and/or contraindications to any product to be given to theparticipant 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 theability of the participant to tolerate CD19 CAR-T cell therapy
Inadequate organ function
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Salvador, Estado de Bahia 41253-190
BrazilActive - Recruiting
Novartis Investigative Site
Salvador 3450554, Estado de Bahia 3471168 41253-190
BrazilSite Not Available
Novartis Investigative Site
Barretos, São Paulo 14784 400
BrazilActive - Recruiting
Novartis Investigative Site
Barretos 3470451, São Paulo 3448433 14784 400
BrazilSite Not Available
Novartis Investigative Site
São Paulo 3448439, São Paulo 3448433 01308-050
BrazilSite Not Available
Novartis Investigative Site
São Paulo, 01509-010
BrazilActive - Recruiting
Novartis Investigative Site
Haifa, 3109601
IsraelActive - Recruiting
Novartis Investigative Site
Haifa 294801, 3109601
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan, 5265601
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan 293788, 5265601
IsraelSite Not Available
Novartis Investigative Site
Sapporo, Hokkaido 060-8648
JapanActive - Recruiting
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanSite Not Available
Novartis Investigative Site
Sapporo 2128295, Hokkaido 2130037 0608648
JapanSite Not Available
Novartis Investigative Site
Kobe, Hyōgo 6500047
JapanActive - Recruiting
Novartis Investigative Site
Kobe 1859171, Hyōgo 1862047 6500047
JapanSite Not Available
Novartis Investigative Site
Kanazawa, Ishikawa 920 8641
JapanSite Not Available
Novartis Investigative Site
Kanazawa 1860243, Ishikawa-ken 1861387 920 8641
JapanSite Not Available
Novartis Investigative Site
Sendai, Miyagi 9808574
JapanActive - Recruiting
Novartis Investigative Site
Sendai city, Miyagi 980 8574
JapanSite Not Available
Novartis Investigative Site
Sendai 2111149, Miyagi 2111888 9808574
JapanSite Not Available
Novartis Investigative Site
Suita, Osaka 565-0871
JapanActive - Recruiting
Novartis Investigative Site
Suita 1851483, Osaka 1853904 5650871
JapanSite Not Available
Novartis Investigative Site
Bunkyo Ku, Tokyo 1138431
JapanActive - Recruiting
Novartis Investigative Site
Shinjuku-ku, Tokyo 1608582
JapanActive - Recruiting
Novartis Investigative Site
Chiba, 2608677
JapanActive - Recruiting
Novartis Investigative Site
Chiba 2113015, 260 8677
JapanSite Not Available
Novartis Investigative Site
Fukuoka, 8128582
JapanActive - Recruiting
Novartis Investigative Site
Fukuoka 1863967, 8128582
JapanSite Not Available
Novartis Investigative Site
Ishikawa, 9208641
JapanActive - Recruiting
Novartis Investigative Site
Kyoto, 6068507
JapanActive - Recruiting
Novartis Investigative Site
Kyoto 1857910, 6068507
JapanSite Not Available
Novartis Investigative Site
Riyadh, 11211
Saudi ArabiaActive - Recruiting
Novartis Investigative Site
Riyadh 108410, 11211
Saudi ArabiaSite Not Available
Novartis Investigative Site
Singapore, 119074
SingaporeActive - Recruiting
Novartis Investigative Site
Singapore 1880252, S308433
SingaporeSite Not Available
Novartis Investigative Site
Basel, 4031
SwitzerlandActive - Recruiting
Novartis Investigative Site
Basel 2661604, 4031
SwitzerlandSite Not Available
Novartis Investigative Site
Bern, 3010
SwitzerlandActive - Recruiting
Novartis Investigative Site
Bern 2661552, 3010
SwitzerlandSite Not Available
Novartis Investigative Site
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Novartis Investigative Site
Cambridge 2653941, CB2 0QQ
United KingdomSite Not Available
Novartis Investigative Site
London, W12 0HS
United KingdomActive - Recruiting
Novartis Investigative Site
London 2643743, W12 0HS
United KingdomSite Not Available
Novartis Investigative Site
Manchester, M13 9WL
United KingdomActive - Recruiting
University Of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
University Of Colorado
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United StatesActive - Recruiting
Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751 32224
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Northwestern Memorial Hospital
Evanston, Illinois 60611
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesSite Not Available
Michigan Med University of Michigan
Ann Arbor, Michigan 48109 5271
United StatesActive - Recruiting
University of Minnesota
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Mayo Clinic Rochester
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Oregon Health Sciences University
Portland, Oregon 97239
United StatesActive - Recruiting
Oregon Health Sciences University
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Baylor University Medical Center
Dallas, Texas 75246
United StatesActive - Recruiting
Houston Methodist Hospital
Houston, Texas 77030
United StatesActive - Recruiting
Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
LDS Hospital
Salt Lake City, Utah 84143
United StatesActive - Recruiting
LDS Hospital
Salt Lake City 5780993, Utah 5549030 84143
United StatesSite Not Available

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