Study schema1
Key inclusion criteria2
Patients with progressive forms of MS
- A diagnosis of treatment-resistant PPMS or diagnosis of iSPMS
- An EDSS ≥3.0 or ≤6.0
Key exclusion criteria2
- Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in <240 seconds unless extenuating medical conditions unrelated to MS prohibit this
- Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds
- Other protocol-defined Inclusion/Exclusion criteria apply
Please see ClinicalTrials.gov for more detailed inclusion/exclusion criteria.
Breakfree-2 is a Phase 1, multicenter, single-arm, dose-escalation study of CC-97540 (BMS-986353), CD19-targeted NEX-T CAR T cells in participants with autoimmune neurological diseases2
Primary endpoints2
- Safety (eg, SAEs, dose-limiting toxicities)
- Recommended Phase 2 dose
Select secondary endpoints2
- Number of patients meeting no evidence of disease activity (NEDA) criteria up to Week 104
- Number of patients with confirmed disability progression per EDSS up to Week 12
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CAR=chimeric antigen receptor; DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; iSPMS=inactive secondary progressive multiple sclerosis; MS=multiple sclerosis; PPMS=primary progressive multiple sclerosis; SAE=serious adverse event.
References:
- Pul R, von Tresckow B, Namburi S, et al. A phase 1, multicenter, single-arm, dose-escalation study of BMS-986353 (CC-97540), a CD19-directed chimeric antigen receptor T cell therapy manufactured using a next-generation process, evaluating safety and tolerability in patients with relapsing or progressive forms of multiple sclerosis (Breakfree-2). Presented at: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; February 27-March 1, 2025; West Palm Beach, FL.
- Clinicaltrials.gov. NCT06220201. Accessed March 13, 2025.