Actively Recruiting
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
Led by Novartis Pharmaceuticals · Updated on 2026-05-13
96
Participants Needed
87
Research Sites
408 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
CONDITIONS
Official Title
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must meet 2013 classification criteria for systemic sclerosis and have diffuse cutaneous systemic sclerosis
- Disease onset from first non-Raynaud symptoms within 7 years before screening
- Severe, progressive systemic sclerosis defined by at least one of: interstitial lung disease, severe skin disease, or significant cardiac involvement
- Received all recommended vaccinations for immunocompromised patients
You will not qualify if you...
- Conditions preventing medication washout or eligibility for anti-CD19 CAR-T therapy
- History of hypersensitivity to ingredients in rapcabtagene autoleucel or rituximab
- Rituximab treatment deemed inappropriate by investigator
- Medical conditions unrelated to systemic sclerosis that limit ability to tolerate lymphodepletion and CAR-T therapy
- Other rheumatic diseases besides diffuse cutaneous systemic sclerosis, except secondary Sjogren's syndrome or scleroderma myopathy
- Pre-existing pulmonary hypertension
- Significant kidney disease at screening
- Uncontrolled stage II hypertension at screening
- Vaccination with live attenuated vaccines within 6 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 87 locations
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
3
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
4
Sutter Health Network
San Pablo, California, United States, 94806
Actively Recruiting
5
FL Medical Clinic Orlando Health
Zephyrhills, Florida, United States, 33542
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
University Of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
9
Michigan Med University of Michigan
Ann Arbor, Michigan, United States, 48109 5271
Actively Recruiting
10
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
James Cancer Hospital
Columbus, Ohio, United States, 43210
Actively Recruiting
12
Oregon Health Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
13
Avera Cancer
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
14
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
15
Novartis Investigative Site
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
16
Novartis Investigative Site
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
17
Novartis Investigative Site
Graz, Austria, 8036
Actively Recruiting
18
Novartis Investigative Site
Vienna, Austria, 1090
Actively Recruiting
19
Novartis Investigative Site
Ghent, Belgium, 9000
Actively Recruiting
20
Novartis Investigative Site
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
21
Novartis Investigative Site
Barretos, São Paulo, Brazil, 14784 400
Actively Recruiting
22
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01232-010
Actively Recruiting
23
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 01308-050
Actively Recruiting
24
Novartis Investigative Site
Olomouc, Czechia, 779 00
Actively Recruiting
25
Novartis Investigative Site
Prague, Czechia, 128 00
Actively Recruiting
26
Novartis Investigative Site
Aarhus N, Denmark, 8200
Actively Recruiting
27
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
28
Novartis Investigative Site
Dijon, France, 21000
Actively Recruiting
29
Novartis Investigative Site
Lille, France, 59037
Actively Recruiting
30
Novartis Investigative Site
Lyon, France, 69003
Actively Recruiting
31
Novartis Investigative Site
Montpellier, France, 34295
Actively Recruiting
32
Novartis Investigative Site
Paris, France, 75014
Actively Recruiting
33
Novartis Investigative Site
Rennes, France, 35033
Actively Recruiting
34
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
35
Novartis Investigative Site
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
36
Novartis Investigative Site
Leipzig, Saxony, Germany, 04103
Actively Recruiting
37
Novartis Investigative Site
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
38
Novartis Investigative Site
Jena, Thuringia, Germany, 07740
Actively Recruiting
39
Novartis Investigative Site
Berlin, Germany, 13353
Actively Recruiting
40
Novartis Investigative Site
Lübeck, Germany, 23538
Actively Recruiting
41
Novartis Investigative Site
Mainz, Germany, 55131
Actively Recruiting
42
Novartis Investigative Site
Nuremberg, Germany, 90419
Actively Recruiting
43
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
44
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
Actively Recruiting
45
Novartis Investigative Site
Budapest, Hungary, H-1083
Actively Recruiting
46
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
47
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
48
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
49
Novartis Investigative Site
Ancona, AN, Italy, 60126
Actively Recruiting
50
Novartis Investigative Site
Bergamo, BG, Italy, 24127
Actively Recruiting
51
Novartis Investigative Site
Brescia, BS, Italy, 25123
Actively Recruiting
52
Novartis Investigative Site
Genova, GE, Italy, 16132
Actively Recruiting
53
Novartis Investigative Site
Milan, MI, Italy, 20122
Actively Recruiting
54
Novartis Investigative Site
Milan, MI, Italy, 20132
Actively Recruiting
55
Novartis Investigative Site
Pescara, PE, Italy, 65124
Actively Recruiting
56
Novartis Investigative Site
Perugia, PG, Italy, 06129
Actively Recruiting
57
Novartis Investigative Site
Pisa, PI, Italy, 56126
Actively Recruiting
58
Novartis Investigative Site
Pavia, PV, Italy, 27100
Actively Recruiting
59
Novartis Investigative Site
Roma, RM, Italy, 00168
Actively Recruiting
60
Novartis Investigative Site
Udine, UD, Italy, 33100
Actively Recruiting
61
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
62
Novartis Investigative Site
Sendai, Miyagi, Japan, 9808574
Actively Recruiting
63
Novartis Investigative Site
Suita, Osaka, Japan, 565-0871
Actively Recruiting
64
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8603
Actively Recruiting
65
Novartis Investigative Site
Fukuoka, Japan, 8128582
Actively Recruiting
66
Novartis Investigative Site
Ishikawa, Japan, 9208641
Actively Recruiting
67
Novartis Investigative Site
Kyoto, Japan, 6068507
Actively Recruiting
68
Novartis Investigative Site
Utrecht, Netherlands, 3584 CX
Actively Recruiting
69
Novartis Investigative Site
Singapore, Singapore, 169608
Actively Recruiting
70
Novartis Investigative Site
Seoul, South Korea, 04763
Actively Recruiting
71
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
72
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
Actively Recruiting
73
Novartis Investigative Site
Santander, Cantabria, Spain, 39008
Actively Recruiting
74
Novartis Investigative Site
Pamplona, Navarre, Spain, 31008
Actively Recruiting
75
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
76
Novartis Investigative Site
Barcelona, Spain, 08041
Actively Recruiting
77
Novartis Investigative Site
Córdoba, Spain, 14004
Actively Recruiting
78
Novartis Investigative Site
Madrid, Spain, 28009
Actively Recruiting
79
Novartis Investigative Site
Madrid, Spain, 28041
Actively Recruiting
80
Novartis Investigative Site
Málaga, Spain, 29010
Actively Recruiting
81
Novartis Investigative Site
Salamanca, Spain, 37007
Actively Recruiting
82
Novartis Investigative Site
Valencia, Spain, 46026
Actively Recruiting
83
Novartis Investigative Site
Geneva, Switzerland, 1211
Actively Recruiting
84
Novartis Investigative Site
Lausanne, Switzerland, 1011
Actively Recruiting
85
Novartis Investigative Site
Zurich, Switzerland, 8091
Actively Recruiting
86
Novartis Investigative Site
Taichung, Taiwan, 407219
Actively Recruiting
87
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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