A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacaptagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
Public ClinicalTrials.gov record NCT07335562. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)
Study identification
- NCT ID
- NCT07335562
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Industry
- Enrollment
- 92 participants
Conditions and interventions
Conditions
Interventions
- BMS-986353 Drug
- Cyclophosphamide Drug
- Fludarabine Drug
- Nintedanib Drug
- Rituximab Drug
- Tocilizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 29, 2026
- Primary completion
- Nov 13, 2028
- Completion
- Nov 10, 2030
- Last update posted
- Mar 4, 2026
2026 – 2030
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0035 | Scottsdale | Arizona | 85259 | — |
| Local Institution - 0092 | Aurora | Colorado | 80045 | — |
| Local Institution - 0001 | Denver | Colorado | 80218 | — |
| Local Institution - 0069 | Miami | Florida | 33136 | — |
| Local Institution - 0014 | Atlanta | Georgia | 30322 | — |
| Local Institution - 0139 | Chicago | Illinois | 60611 | — |
| Local Institution - 0084 | Worcester | Massachusetts | 01655 | — |
| Local Institution - 0034 | Ann Arbor | Michigan | 48109 | — |
| Local Institution - 0037 | Rochester | Minnesota | 55905 | — |
| Local Institution - 0082 | Summit | New Jersey | 07901 | — |
| Local Institution - 0122 | Cleveland | Ohio | 44195 | — |
| Local Institution - 0002 | Charleston | South Carolina | 29425 | — |
| Local Institution - 0074 | Dallas | Texas | 75390 | — |
| Local Institution - 0008 | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07335562, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 4, 2026 · Synced Apr 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07335562 live on ClinicalTrials.gov.