Phase
Condition
Idiopathic Inflammatory Myopathies
Collagen Vascular Diseases
Lupus
Treatment
Rapcabtagene autoleucel
Active Comparator Option
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 probable or definitemyositis according to American College of Rheumatology/European League AgainstRheumatism 2017 (ACR/EULAR 2017) criteria
Participants who had inadequate response to prior therapy
Diagnosed with active disease
Participant must meet criteria for severe myositis
Exclusion
Key Exclusion Criteria:
Any condition during Screening that could prevent a complete washout of medicationsor could otherwise make the participant ineligible for anti-CD19 CAR-T therapy andfurther participation in the study
BMI at Screening of ≤17 or ≥40 kg/m2
Severe muscle damage at Screening
Inadequate organ function
Hypersensitivity and/or contraindications to any product (including its ingredients)to be given to the participant as per the study protocol
Other inflammatory and non-inflammatory myopathies
Any medical conditions that are not related to IIM that would jeopardize the abilityof the participant to tolerate CD19 CAR-T cell therapy
Other protocol-defined inclusion/exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Brest, 29200
FranceSite Not Available
Novartis Investigative Site
Brest 3030300, 29200
FranceActive - Recruiting
Novartis Investigative Site
Lille 2998324, 59037
FranceSuspended
Novartis Investigative Site
Lyon, 69003
FranceSite Not Available
Novartis Investigative Site
Lyon 2996944, 69003
FranceActive - Recruiting
Novartis Investigative Site
Paris, 75013
FranceSite Not Available
Novartis Investigative Site
Paris 2988507, 75013
FranceActive - Recruiting
Novartis Investigative Site
Paris 13, 75651
FranceSite Not Available
Novartis Investigative Site
Rennes, 35000
FranceSite Not Available
Novartis Investigative Site
Rennes 2983990, 35033
FranceActive - Recruiting
Novartis Investigative Site
Cologne 2886242, North Rhine-Westphalia 2861876 50937
GermanyActive - Recruiting
Novartis Investigative Site
Leipzig, Sachsen 04103
GermanySite Not Available
Novartis Investigative Site
Leipzig 2879139, Saxony 2842566 04103
GermanyActive - Recruiting
Novartis Investigative Site
Jena 2895044, Thuringia 2822542 07740
GermanyActive - Recruiting
Novartis Investigative Site
Aachen 3247449, 52074
GermanyActive - Recruiting
Novartis Investigative Site
Hamburg, 20246
GermanySite Not Available
Novartis Investigative Site
Hamburg 2911298, 20246
GermanyActive - Recruiting
Novartis Investigative Site
Jena, 07740
GermanySite Not Available
Novartis Investigative Site
Koeln, 50937
GermanySite Not Available
Novartis Investigative Site
Mainz 2874225, 55131
GermanyActive - Recruiting
Novartis Investigative Site
Nuremberg 2861650, 90419
GermanyActive - Recruiting
Novartis Investigative Site
Ulm 2820256, 89081
GermanyActive - Recruiting
Novartis Investigative Site
Haifa, 3109601
IsraelSite Not Available
Novartis Investigative Site
Haifa 294801, 3109601
IsraelActive - Recruiting
Novartis Investigative Site
Ramat Gan, 5265601
IsraelSite Not Available
Novartis Investigative Site
Ramat Gan 293788, 5265601
IsraelActive - Recruiting
Novartis Investigative Site
Tel Aviv, 6423906
IsraelSite Not Available
Novartis Investigative Site
Tel Aviv 293397, 6423906
IsraelActive - Recruiting
Novartis Investigative Site
Brescia, BS 25123
ItalySite Not Available
Novartis Investigative Site
Brescia 3181554, BS 25123
ItalyActive - Recruiting
Novartis Investigative Site
Monza 3172629, MB 20900
ItalyActive - Recruiting
Novartis Investigative Site
Milan 6951411, MI 20122
ItalyActive - Recruiting
Novartis Investigative Site
Milano, MI 20122
ItalySite Not Available
Novartis Investigative Site
Sapporo city, Hokkaido 060 8648
JapanSite Not Available
Novartis Investigative Site
Sapporo 2128295, Hokkaido 2130037 0608648
JapanActive - Recruiting
Novartis Investigative Site
Kanazawa, Ishikawa 920 8641
JapanSite Not Available
Novartis Investigative Site
Kanazawa 1860243, Ishikawa-ken 1861387 920 8641
JapanActive - Recruiting
Novartis Investigative Site
Yokohama 1848354, Kanagawa-ku 236-0004
JapanActive - Recruiting
Novartis Investigative Site
Sendai city, Miyagi 980 8574
JapanSite Not Available
Novartis Investigative Site
Sendai 2111149, Miyagi 2111888 9808574
JapanActive - Recruiting
Novartis Investigative Site
Suita, Osaka 565 0871
JapanSite Not Available
Novartis Investigative Site
Suita 1851483, Osaka 1853904 565 0871
JapanActive - Recruiting
Novartis Investigative Site
Izumo-city, Shimane 693 8501
JapanSite Not Available
Novartis Investigative Site
Izumo 1861084, Shimane 1852442 693 8501
JapanActive - Recruiting
Novartis Investigative Site
Bunkyo-ku, Tokyo 1850144 1138519
JapanActive - Recruiting
Novartis Investigative Site
Shinjuku-ku, Tokyo 1850144 1608582
JapanActive - Recruiting
Novartis Investigative Site
Fukuoka 1863967, 8128582
JapanActive - Recruiting
Novartis Investigative Site
Kyoto, 606 8507
JapanSite Not Available
Novartis Investigative Site
Kyoto 1857910, 6068507
JapanActive - Recruiting
Novartis Investigative Site
Amsterdam 2759794, North Holland 2749879 1105 AZ
NetherlandsActive - Recruiting
Novartis Investigative Site
Singapore, S308433
SingaporeSite Not Available
Novartis Investigative Site
Singapore 1880252, S308433
SingaporeActive - Recruiting
Novartis Investigative Site
Santiago Compostela, A Coruna 15706
SpainActive - Recruiting
Novartis Investigative Site
Barcelona, Catalunya 08035
SpainSite Not Available
Novartis Investigative Site
Pamplona, Navarra 31008
SpainSite Not Available
Novartis Investigative Site
Pamplona 3114472, Navarre 3115609 31008
SpainActive - Recruiting
Novartis Investigative Site
Barcelona 3128760, 08035
SpainActive - Recruiting
Novartis Investigative Site
Córdoba 2519240, 14004
SpainActive - Recruiting
Novartis Investigative Site
Madrid 3117735, 28041
SpainActive - Recruiting
Novartis Investigative Site
Málaga 2514256, 29010
SpainActive - Recruiting
Novartis Investigative Site
Salamanca 3111108, 37007
SpainActive - Recruiting
Novartis Investigative Site
Kaohsiung City 1673820, 83301
TaiwanActive - Recruiting
Novartis Investigative Site
Taichung, 407219
TaiwanSite Not Available
Novartis Investigative Site
Taichung 1668399, 407219
TaiwanActive - Recruiting
Novartis Investigative Site
Taipei, 10002
TaiwanSite Not Available
Novartis Investigative Site
Taipei 1668341, 10002
TaiwanActive - Recruiting
Novartis Investigative Site
Sheffield 2638077, South Yorkshire S10 2JF
United KingdomActive - Recruiting
Novartis Investigative Site
London 2643743, NW1 2BU
United KingdomActive - Recruiting
University Of Alabama
Birmingham 4049979, Alabama 4829764 35294
United StatesActive - Recruiting
FL Medical Clinic Orlando Health
Zephyrhills 4178941, Florida 4155751 33542
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Northwestern University
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
University Of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
University Of Iowa
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
LDS Hospital
Salt Lake City, Utah 84143
United StatesSite Not Available
LDS Hospital
Salt Lake City 5780993, Utah 5549030 84143
United StatesActive - Recruiting

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