Trial intelligence / Profile preview

Breakfree-SSc: BMS-986353 NEX-T CAR T Cells vs Standard of Care in Systemic Sclerosis

jRCT2033260131Phase 3Not yet recruiting

Sponsor
Bristol Myers Squibb
Start
Jul 2026
Modality
CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
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Overview

Phase 3, randomised, open-label trial in systemic sclerosis (SSc) and pulmonary fibrosis secondary to systemic sclerosis (SSc-ILD) comparing BMS-986353 NEX-T CAR T Cells + Lymphodepletion with Standard of Care: Tocilizumab + Rituximab + Nintedanib (2 arms). Primary endpoint: Change in Forced Vital Capacity at 12 Months. Planned start Jul 2026; status: not yet recruiting.

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Drugs

BMS-986353
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Conditions

systemic sclerosis (SSc)pulmonary fibrosis secondary to systemic sclerosis (SSc-ILD)

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