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Breakfree-SSc: BMS-986353 CD19-targeted NEX-T CAR T vs Standard of Care in Active Systemic Sclerosis
2025-524337-11-00Phase 3Authorised
- Sponsor
- Celgene Corporation
- Start
- Jun 2026
- Modality
- CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
- Countries
- 10
01
Overview
Phase 3, randomised, open-label trial in systemic sclerosis (SSc) comparing BMS-986353 CD19-targeted NEX-T CAR T with Standard of care (2 arms). Primary endpoint: Change in Forced Vital Capacity (FVC, mL). Planned start Jun 2026; status: authorised.
02
Drugs
BMS-986353
03
Conditions
systemic sclerosis (SSc)
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