Study schema1
Key inclusion criteria2
Patients with an SLE diagnosis fulfilling the 2019 EULAR/ACR classification
- Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening
- Active disease at screening, with recent ≥1 major organ system with a BILAG A score
- Inadequate response to glucocorticoids and other therapies
Key exclusion criteria2
Patients diagnosed with drug-induced SLE or other systemic autoimmune diseases
- Present or recent clinically significant CNS pathology within 12 months
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 patients achieving definition of remission in SLE (DORIS) remission at Week 24
- Proportion of patients achieving Lupus Low Disease Activity State (LLDAS) at Week 24
- Change in proteinuria measured by UPCR at Week 24
Find a study site today
ACR=American College of Rheumatology; BILAG=British Isles Lupus Assessment Group; CAR=chimeric antigen receptor; CNS=central nervous system; DM=dermatomyositis; EULAR=European League Against Rheumatism; SAE=serious adverse event; TEAE=treatment-emergent adverse event; UPCR=urine protein-creatinine ratio.
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.