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 (NCT07335562)
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)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Local Institution - 0035 — Scottsdale, Arizona
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (56 Sites)
Showing the first 25 of 56 sites.
- Local Institution - 0035 — Scottsdale, Arizona
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Local Institution - 0001 — Denver, Colorado
- Local Institution - 0069 — Miami, Florida
- Emory University School of Medicine — Atlanta, Georgia
- Local Institution - 0139 — Chicago, Illinois
- Local Institution - 0084 — Worcester, Massachusetts
- Local Institution - 0034 — Ann Arbor, Michigan
- Local Institution - 0037 — Rochester, Minnesota
- Local Institution - 0082 — Summit, New Jersey
- Cleveland Clinic — Cleveland, Ohio
- Local Institution - 0142 — Philadelphia, Pennsylvania
- Local Institution - 0143 — Pittsburgh, Pennsylvania
- Local Institution - 0002 — Charleston, South Carolina
- Local Institution - 0074 — Dallas, Texas
- Local Institution - 0144 — Houston, Texas
- Local Institution - 0008 — Seattle, Washington
- Local Institution - 0057 — Leuven, Vlaams-Brabant
- Local Institution - 0080 — Liège,
- Local Institution - 0104 — Halifax, Nova Scotia
- Local Institution - 0088 — Sherbrooke, Quebec
- Local Institution - 0031 — Strasbourg, Alsace
- Local Institution - 0061 — Toulouse, Haute-Garonne
- Local Institution - 0049 — Bordeaux,
- Local Institution - 0012 — Bron,
📞 Contact the Study Coordinator
Phone: (855) 907-3286
Email: Clinical.Trials@bms.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Systemic Sclerosis
- KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis — Palo Alto, California
- Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY) — Scottsdale, Arizona
- Hyaluronidase for Sclerodactyly in Systemic Sclerosis Trial — Charleston, South Carolina
- Belimumab and Rituximab Combination Therapy for the Treatment of Diffuse Cutaneous Systemic Sclerosis — New York, New York
- Interrogating the Pathophysiological Mechanisms of Constipation in Patients With Systemic Sclerosis — Houston, Texas
Explore by condition: All Systemic Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.