Actively Recruiting
A Phase 3, Randomized, Open-label Study Comparing BMS-986353 (CD19-CAR T Cells) Versus Standard Care in Active Systemic Sclerosis
Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-05-15
92
Participants Needed
55
Research Sites
103 weeks
Total Duration
On this page
Sponsors
J
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Lead Sponsor
C
Celgene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of BMS-986353, a CD19-targeted NEX-T CAR T cell therapy, compared to the standard of care in people with active Systemic Sclerosis (SSc). This phase 3 randomized, open-label study aims to address treatment challenges in participants who have not responded well or tolerate current immunomodulatory drugs. The trial is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Participants are randomly assigned to receive either BMS-986353 or the standard of care. Those in the standard of care group may receive BMS-986353 if their disease progresses. Several other drugs such as Fludarabine, Cyclophosphamide, Tocilizumab, Rituximab, and Nintedanib are involved in the treatment regimens with specified doses on certain days. The study monitors participants over time to compare the two approaches. During the trial, participants will undergo various assessments including lung function tests measuring Forced Vital Capacity (FVC), skin evaluations using the Modified Rodnan Skin Score (mRSS), and imaging to assess lung disease extent. Patient-reported outcomes on fatigue, disability, and health status are also collected up to 36 months. Safety and disease progression are closely followed, with the primary outcome measured by changes in FVC at 12 months. The total study duration extends to nearly 54 months to capture long-term effects.
CONDITIONS
Brief Title
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet the 2013 ACR/EULAR criteria for Systemic Sclerosis
- Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I antibodies
- Confirmed Interstitial Lung Disease on HRCT with at least 10% lung involvement
- Presence of at least one active SSc symptom: arthritis, myositis, carditis, progressive skin disease, or elevated inflammatory markers
- Non-response or intolerance to at least 6 months of immunomodulatory drug treatment
You will not qualify if you...
- Requirement for supplemental oxygen therapy or DLCO ≤ 40% at screening
- Moderate to severe pulmonary arterial hypertension needing combination treatment
- Pulmonary comorbidities such as COPD or asthma requiring daily oral corticosteroids
- Cigarette smoking, including e-cigarettes, within 3 months before screening or unwillingness to avoid smoking during the study
- Significant abnormalities on HRCT not related to SSc
- Gastrointestinal dysmotility requiring total parenteral nutrition
- Current gangrene of a digit
- Other protocol-defined inclusion or exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment varies based on assigned therapy and participant response
Participants receive either BMS-986353 (CD19-CAR T Cells) or standard of care for active systemic sclerosis according to their assigned arm.
Visits occur as per treatment schedule with specified dosing days
Duration - Up to 36 months
Participants are monitored for safety and efficacy outcomes following treatment.
Periodic visits during follow-up for assessments up to 36 months
Trial Site Locations
Total: 55 locations
1
Local Institution - 0035
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Local Institution - 0001
Denver, Colorado, United States, 80218
Not Yet Recruiting
4
Local Institution - 0069
Miami, Florida, United States, 33136
Not Yet Recruiting
5
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Local Institution - 0139
Chicago, Illinois, United States, 60611
Not Yet Recruiting
7
Local Institution - 0084
Worcester, Massachusetts, United States, 01655
Not Yet Recruiting
8
Local Institution - 0034
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
9
Local Institution - 0037
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
10
Local Institution - 0082
Summit, New Jersey, United States, 07901
Not Yet Recruiting
11
Local Institution - 0122
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
12
Local Institution - 0142
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
13
Local Institution - 0143
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
14
Local Institution - 0002
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
15
Local Institution - 0074
Dallas, Texas, United States, 75390
Not Yet Recruiting
16
Local Institution - 0008
Seattle, Washington, United States, 98109
Not Yet Recruiting
17
Local Institution - 0057
Leuven, Vlaams-Brabant, Belgium, 3000
Not Yet Recruiting
18
Local Institution - 0080
Liège, Belgium, 4000
Not Yet Recruiting
19
Local Institution - 0104
Halifax, Nova Scotia, Canada, B3H2Y9
Not Yet Recruiting
20
Local Institution - 0088
Sherbrooke, Quebec, Canada, J1H 5N4
Not Yet Recruiting
21
Local Institution - 0031
Strasbourg, Alsace, France, 67098
Not Yet Recruiting
22
Local Institution - 0061
Toulouse, Haute-Garonne, France, 31059
Not Yet Recruiting
23
Local Institution - 0049
Bordeaux, France, 33076
Not Yet Recruiting
24
Local Institution - 0012
Bron, France, 69500
Not Yet Recruiting
25
Local Institution - 0052
Paris, France, 75679
Not Yet Recruiting
26
Local Institution - 0141
Rennes, France, 35033
Not Yet Recruiting
27
Local Institution - 0046
Berlin, Germany, 10117
Not Yet Recruiting
28
Local Institution - 0016
Cologne, Germany, 50937
Not Yet Recruiting
29
Local Institution - 0028
Erlangen, Germany, 91054
Not Yet Recruiting
30
Local Institution - 0042
Leipzig, Germany, 04103
Not Yet Recruiting
31
Local Institution - 0032
München, Germany, 80336
Not Yet Recruiting
32
Local Institution - 0033
Tübingen, Germany, 72076
Withdrawn
33
Local Institution - 0038
Würzburg, Germany, 97080
Not Yet Recruiting
34
Local Institution - 0103
Rome, Lazio, Italy, 00168
Not Yet Recruiting
35
Local Institution - 0004
Milan, Milano, Italy, 20162
Not Yet Recruiting
36
Local Institution - 0108
Pisa, Tuscany, Italy, 56126
Not Yet Recruiting
37
Local Institution - 0106
Milan, Italy, 20132
Not Yet Recruiting
38
Local Institution - 0026
Sapporo, Hokkaido, Japan, 0608648
Not Yet Recruiting
39
Local Institution - 0132
Yokohama, Kanagawa, Japan, 236-0004
Not Yet Recruiting
40
Local Institution - 0137
Suita, Osaka, Japan, 565-0871
Not Yet Recruiting
41
Local Institution - 0117
Bunkyo-ku, Tokyo, Japan, 1138603
Not Yet Recruiting
42
Local Institution - 0123
Fukuoka, Japan, 812-8582
Not Yet Recruiting
43
Local Institution - 0136
Maebashi, Japan, 371-8511
Not Yet Recruiting
44
Local Institution - 0118
Okayama, Japan, 700-8558
Not Yet Recruiting
45
Local Institution - 0129
A Coruña, A Coruña [La Coruña], Spain, 15006
Not Yet Recruiting
46
Local Institution - 0138
Barcelona, Catalunya [Cataluña], Spain, 08041
Not Yet Recruiting
47
Local Institution - 0060
Barcelona, Spain, 08907
Not Yet Recruiting
48
Local Institution - 0009
Málaga, Spain, 29011
Not Yet Recruiting
49
Local Institution - 0047
Basel, Switzerland, 4031
Not Yet Recruiting
50
Local Institution - 0068
Bern, Switzerland, 3010
Not Yet Recruiting
51
Local Institution - 0078
Zurich, Switzerland, 8091
Not Yet Recruiting
52
Local Institution - 0140
London, London, City of, United Kingdom, NW1 2PG
Not Yet Recruiting
53
Local Institution - 0063
Leeds, West Yorkshire, United Kingdom, LS8 7TF
Not Yet Recruiting
54
Local Institution - 0091
Sheffield, Yorkshire and the Humber, United Kingdom, S102JF
Not Yet Recruiting
55
Local Institution - 0059
London, United Kingdom, NW3 2QG
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
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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