Actively Recruiting
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
Led by Novartis Pharmaceuticals · Updated on 2026-02-05
123
Participants Needed
55
Research Sites
291 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)
CONDITIONS
Official Title
Phase 2 Study of Rapcabtagene Autoleucel in Myositis
Who Can Participate
Eligibility Criteria
You may qualify if you...
Key
- Men and women, aged ≥ 18 and ≤75 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
- Participants who had inadequate response to prior therapy
- Diagnosed with active disease
- Participant must meet criteria for severe myositis
Key
You will not qualify if you...
- Any condition during Screening 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
- 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 ability of the participant to tolerate CD19 CAR-T cell therapy
Other protocol-defined inclusion/exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 55 locations
1
University Of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
FL Medical Clinic Orlando Health
Zephyrhills, Florida, United States, 33542
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University Of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
7
Novartis Investigative Site
Brest, France, 29200
Actively Recruiting
8
Novartis Investigative Site
Lille, France, 59037
Suspended
9
Novartis Investigative Site
Lyon, France, 69003
Actively Recruiting
10
Novartis Investigative Site
Paris, France, 75013
Actively Recruiting
11
Novartis Investigative Site
Rennes, France, 35033
Actively Recruiting
12
Novartis Investigative Site
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
13
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Actively Recruiting
14
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
15
Novartis Investigative Site
Aachen, Germany, 52074
Actively Recruiting
16
Novartis Investigative Site
Hamburg, Germany, 20246
Actively Recruiting
17
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
18
Novartis Investigative Site
Nuremberg, Germany, 90419
Actively Recruiting
19
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
20
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
21
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
22
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
23
Novartis Investigative Site
Brescia, BS, Italy, 25123
Actively Recruiting
24
Novartis Investigative Site
Monza, MB, Italy, 20900
Actively Recruiting
25
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
26
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 0608648
Actively Recruiting
27
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan, 920 8641
Actively Recruiting
28
Novartis Investigative Site
Yokohama, Kanagawa-ku, Japan, 236-0004
Actively Recruiting
29
Novartis Investigative Site
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
30
Novartis Investigative Site
Suita, Osaka, Japan, 565 0871
Actively Recruiting
31
Novartis Investigative Site
Izumo, Shimane, Japan, 693 8501
Actively Recruiting
32
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
33
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 1138519
Actively Recruiting
34
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 1608582
Actively Recruiting
35
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
36
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
37
Novartis Investigative Site
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
38
Novartis Investigative Site
Riyadh, Saudi Arabia, 11211
Actively Recruiting
39
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
40
Novartis Investigative Site
Singapore, Singapore, 169608
Actively Recruiting
41
Novartis Investigative Site
Singapore, Singapore, S308433
Actively Recruiting
42
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
43
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Actively Recruiting
44
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
45
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
46
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
47
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
48
Novartis Investigative Site
Málaga, Spain, 29010
Actively Recruiting
49
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
50
Novartis Investigative Site
Geneva, Switzerland, 1211
Actively Recruiting
51
Novartis Investigative Site
Kaohsiung City, Taiwan, 83301
Actively Recruiting
52
Novartis Investigative Site
Taichung, Taiwan, 407219
Actively Recruiting
53
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
54
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
55
Novartis Investigative Site
London, United Kingdom, NW1 2BU
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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