Study schema1
Key inclusion criteria2
Patients with an IIM diagnosis fulfilling the 2017 EULAR/ACR classification, including the DM, IMNM, ASyS, and PM subgroups
- Presence of at at least 1 myositis-specific antibody (MSA), myositis-associated antibody (MAA), or ANA at screening or prior to screening
- Severe muscle and/or skin involvement
- Proof of disease activity
Key exclusion criteria2
Patients diagnosed with other forms of IIM such as inclusion body myositis, amyopathic DM, any form of juvenile myositis and/or drug-induced myositis, and PM associated with HIV
- Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index >7 cm on a 10-cm scale) or permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement
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 Myositis Response Criteria (MRC) Total Improvement Score (TIS) major response at Week 24
- For patients with DM, change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at Week 24
- Proportion of patients with ILD with no worsening pulmonary function, including FEV1 (>10%) and DLCO (>15%), at Week 24
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ACR=American College of Rheumatology; ANA=antinuclear antibody; ASyS=antisynthetase syndrome; CAR=chimeric antigen receptor; DLCO=diffusing capacity of the lung for carbon monoxide; DM=dermatomyositis; EULAR=European League Against Rheumatism; FEV1=forced expiratory volume; ILD=interstitial lung disease; IMNM=immune-mediated necrotizing myopathy; PM=polymyositis; SAE=serious adverse event; TEAE=treatment-emergent adverse event; VAS=visual analogue scale.
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.