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
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Study identification
- NCT ID
- NCT07335562
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 92 participants
Conditions and interventions
Conditions
Interventions
- BMS-986353 Drug
- Fludarabine Drug
- Cyclophosphamide Drug
- Tocilizumab Drug
- Rituximab Drug
- Nintedanib Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 3, 2027 (Estimated)
- Primary completion
- Nov 14, 2028 (Estimated)
- Completion
- Nov 11, 2030 (Estimated)
- Last update posted
- Sep 18, 2026
2027 – 2030
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0035 | Scottsdale | Arizona | 85259 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | — |
| Local Institution - 0069 | Miami | Florida | 33136 | — |
| Emory University School of Medicine | 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 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Local Institution - 0142 | Philadelphia | Pennsylvania | 19104 | — |
| Local Institution - 0143 | Pittsburgh | Pennsylvania | 15224 | — |
| Local Institution - 0002 | Charleston | South Carolina | 29425 | — |
| Local Institution - 0074 | Dallas | Texas | 75390 | — |
| Local Institution - 0144 | Houston | Texas | 77030 | — |
| 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 39 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 Sep 18, 2026 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT07335562 live on ClinicalTrials.gov.