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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

RecruitingPhase 1

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

Conditions: Multiple Sclerosis, Myasthenia Gravis

Interventions: CC-97540, Fludarabine, Cyclophosphamide

Countries: United States, Belgium, France, Germany, Spain, United Kingdom

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria

\- 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.

Exclusion Criteria

* 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.

Locations (35)

Birmingham, Alabama, United States
Irvine, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
North Haven, Connecticut, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
New York, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Edegem, Antwerpen, Belgium
Ghent, Oost-Vlaanderen, Belgium
Lille, Nord, France
Paris, Ville de Paris, France
Essen, North Rhine-Westphalia, Germany
Magdeburg, Saxony-Anhalt, Germany
Düsseldorf, Germany
Erlangen, Germany
München, Germany
Barcelona, Barcelona [Barcelona], Spain
Barcelona, Barcelona [Barcelona], Spain
Barcelona, Catalunya [Cataluña], Spain
Madrid, Madrid, Comunidad de, Spain
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