Trials / Not Yet Recruiting
Not Yet RecruitingNCT07335562
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
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)
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 92 (estimated)
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-986353 | Specified dose on specified days |
| DRUG | Fludarabine | Specified dose on specified days |
| DRUG | Cyclophosphamide | Specified dose on specified days |
| DRUG | Tocilizumab | Specified dose on specified days |
| DRUG | Rituximab | Specified dose on specified days |
| DRUG | Nintedanib | Specified dose on specified days |
Timeline
- Start date
- 2026-04-30
- Primary completion
- 2028-11-14
- Completion
- 2030-11-11
- First posted
- 2026-01-13
- Last updated
- 2026-03-05
Locations
54 sites across 10 countries: United States, Belgium, Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07335562. Inclusion in this directory is not an endorsement.