Study schema1
Key inclusion criteria2
Patients with MG
- MGFA classification of II-IV at screening
- Documented autoantibodies against AChR or MuSK (historical or at screening)
- Refractory disease defined as active despite ≥2 immunosuppressants
- History of thymectomy
Key exclusion criteria2
- Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome
- 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, TEAEs, SAEs, dose-limiting toxicities)
- Recommended Phase 2 dose
Select secondary endpoints2
- Number of patients with a ≥2-point improvement for at least 4 weeks in Myasthenia Gravis Activities of Daily Living (MG-ADL) score up to Week 26
- Number of patients with at least a 3-point improvement in Myasthenia Gravis Composite (MG-C) score up to Week 26
- Number of participants with at least 3 point improvement in quantitative Myasthenia Gravis (QMG) score up to Week 26
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AChR=acetylcholine receptor; CAR=chimeric antigen receptor; MG=myasthenia gravis; MGFA=Myasthenia Gravis Foundation of America; MuSK=muscle-specific kinase; SAE=serious adverse event; TEAE=treatment-emergent adverse event.
References:
- Data on file. REF-06708-IMM. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
- Clinicaltrials.gov. NCT06220201. Accessed March 13, 2025.