A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2) (NCT06220201)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. \- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1. i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months. \- Progressive forms of MS - Cohort 2. i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0. ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS). \- Myasthenia Gravis - Cohort 3 i)MGFA classification of II-IV at screening ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening) iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics. iv) Has had thymectomy, only if indicated according to current guidelines.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (34 Sites)

• Local Institution - 0011 — Birmingham, Alabama
• University of California, Irvine — Irvine, California
• University of Colorado Anschutz Medical Campus — Aurora, Colorado
• Colorado Blood Cancer Institute — Denver, Colorado
• Yale-New Haven Hospital — North Haven, Connecticut
• University of Kansas Medical Center — Kansas City, Kansas
• Local Institution - 0005 — Boston, Massachusetts
• Washington University School of Medicine — St Louis, Missouri
• Hackensack University Medical Center — Hackensack, New Jersey
• Icahn School of Medicine at Mount Sinai — New York, New York
• Neurological Institute of New York — New York, New York
• University of Cincinnati Medical Center — Cincinnati, Ohio
• Cleveland Clinic Mellen Center — Cleveland, Ohio
• Oregon Health and Science University — Portland, Oregon
• Swedish Medical Center — Seattle, Washington
• Medical College of Wisconsin — Milwaukee, Wisconsin
• Antwerp University Hospital — Edegem, Antwerpen
• UZ Gent — Ghent, Oost-Vlaanderen
• Hopital Claude Huriez - CHU de Lille — Lille, Nord
• Pitie Salpetriere University Hospital — Paris, Ville de Paris
• Universitaetsklinikum Essen — Essen, North Rhine-Westphalia
• Universitaetsklinikum Magdeburg — Magdeburg, Saxony-Anhalt
• Local Institution - 0033 — Düsseldorf,
• Universitaetsklinikum Erlangen — Erlangen,
• Klinikum der Universität München Großhadern — München,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.