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)

Running, not enrolling · Phase 1

Conditions studied: Multiple Sclerosis, Myasthenia Gravis

In brief

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).

Key facts

Study ID

NCT06220201

Run by

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

People needed

120

Starts

2024-03-28

Expected to finish

2027-07-15

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Cohorts 1 and 2: 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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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