Study schema1
Key inclusion criteria2
Patients with an SSc diagnosis fulfilling 2013 EULAR/ACR classification
- ANA positive at screening or prior to screening
- SSc disease activity
Key exclusion criteria2
Patients with SSc-related PAH requiring active treatment
- Rapidly progressive SSc-related lower GI involvement (requiring parenteral nutrition); active gastric antral vascular ectasia
- Prior scleroderma renal crisis
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
- Patients with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24
- Worsening of pulmonary function, including FVC (>10% absolute) and DLCO (>15% absolute decline), in patients with ILD at Week 24
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ACR=American College of Rheumatology; ANA=antinuclear antibody; CAR=chimeric antigen receptor; DLCO=diffusing capacity of the lung for carbon monoxide; EULAR=European League Against Rheumatism; FVC=forced vital capacity; GI=gastrointestinal; ILD=interstitial lung disease; PAH=pulmonary arterial hypertension; SAE=serious adverse event; TEAE=treatment-emergent adverse event.
References:
- Müller F, Patel K, Reshef R, et al. Tolerability, efficacy, pharmacokinetics, and pharmacodynamics of BMS-986353 (CC-97540), a CD-19 directed chimeric antigen receptor T cell therapy manufactured using a next-generation process, for severe, refractory autoimmune diseases: updated data from ongoing phase 1, multicenter, open-label studies [Abstract 2088]. Presented at: 66th American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024; San Diego, CA.
- Clinicaltrials.gov. NCT05869955. Accessed March 12, 2025.