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)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria \- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies. ii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:. A. Arthritis. B. Myositis. C. Car…
Interventions
- DrugBMS-986353
Specified dose on specified days
- DrugFludarabine
Specified dose on specified days
- DrugCyclophosphamide
Specified dose on specified days
- DrugTocilizumab
Specified dose on specified days
- DrugRituximab
Specified dose on specified days
- DrugNintedanib
Specified dose on specified days
Locations (54)
- Local Institution - 0035Scottsdale, Arizona
- Local Institution - 0092Aurora, Colorado
- Local Institution - 0001Denver, Colorado
- Local Institution - 0069Miami, Florida
- Local Institution - 0014Atlanta, Georgia
- Local Institution - 0139Chicago, Illinois