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)
Purpose
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).
Conditions
- Multiple Sclerosis
- Myasthenia Gravis
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Administration of CC-97540 (RMS arm) |
|
|
|
Experimental Administration of CC-97540 (PMS arm) |
|
|
|
Experimental Administration of CC-97540 (MG arm) |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Contact:
Sharon Lynch, Site 0003
913-588-6980
Sharon Lynch, Site 0003
913-588-6980
More Details
- Status
- Recruiting
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com