clinical trial · NCT07335562
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
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company·phase3·not yet recruiting·n = 92
Systemic SclerosisBMS-986353FludarabineCyclophosphamideTocilizumabRituximabNintedanib
brief 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
started
Apr 30, 2026
primary completion
Nov 14, 2028
completion
Nov 11, 2030
last updated
Mar 5, 2026
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol