Status:
RECRUITING
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)
Lead Sponsor:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Collaborating Sponsors:
Celgene Corporation
Conditions:
Multiple Sclerosis
Myasthenia Gravis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06220201
Start Date
March 28 2024
End Date
July 15 2027
Last Update
December 23 2025
Active Locations (35)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of California, Irvine
Irvine, California, United States, 92697
3
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
4
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218