Long title
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD-19-targeted NEXT-T CAR-T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)
Date receipt dossier
EudraCT number
2025-524337-11
Company / Sponsor
Celgene
Phase
III
Treated organism
Humans
Indication category
Immune disease
Disease
Active Systemic Sclerosis
Therapeutic approach
Immunotherapy
Genetic modification
CD19 CAR
Method of transfer of nucleic acid of interest
Lentiviral vector
Administered biological material
Autologous T cells transduced with lentiviral vectors expressing CD19-CAR
Route of administration
Intravenous
Locations in Belgium
UZ Leuven-KU Leuven
Nr of subjects
37 subsjects (4 participants in Belgium)
Foreseen duration
12/3/2026 - 11/11/2030
Type of procedure
Contained use only
Current status
Authorized
Pharmaceutical study code
CC-97540 (BMS-986353)