Breakfree-1 clinical trial for rheumatoid arthritis (RA)

Study schema¹

Breakfree-1 clinical trial study schema

Plus

Key inclusion criteria²

Minimum of 3 SJC and 3 TJC on a 66/68 joint count (SJC/TJC)
Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, nintedanib, azathioprine, tocilizumab, or intravenous immunoglobulins (IVIG)

Minus

Key exclusion criteria²

Prior history of or current inflammatory joint disease other than RA
Joint damage and/or deformity that may confound the investigator's ability to accurately assess disease activity
Other protocol-defined Inclusion/Exclusion criteria apply

Please see ClinicalTrials.gov for more detailed inclusion/exclusion criteria.

Breakfree-1 is a Phase 1, multicenter, open-label study of CC-97540 (BMS-986353), CD19-targeted NEX-T CAR T cells, in participants with severe, refractory autoimmune diseases²

Primary endpoints²

Safety (eg, TEAEs, SAEs, dose-limiting toxicities)
Recommended Phase 2 dose

Select secondary endpoints²

Proportion of participants achieving low Disease Activity Score-28 Joint C-reactive protein (DAS28-CRP)
Proportion of participants achieving simplified disease activity index (SDAI) remission
Proportion of participants with ILD with no worsening of pulmonary function including FVC (>10%)

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FEV1=forced expiratory volume; FVC=forced vital capacity; ILD=interstitial lung disease; IMNM=immune-mediated necrotizing myopathy; SAE=serious adverse event; SJC=swollen joint count; TEAE=treatment-emergent adverse event; TJC=tender joint count; VAS=visual analogue scale.