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

ArmDescriptionAssigned Intervention
Experimental
Administration of CC-97540 (RMS arm)
  • Drug: CC-97540
    Specified dose on specified days
    Other names:
    • BMS-986353
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days
Experimental
Administration of CC-97540 (PMS arm)
  • Drug: CC-97540
    Specified dose on specified days
    Other names:
    • BMS-986353
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days
Experimental
Administration of CC-97540 (MG arm)
  • Drug: CC-97540
    Specified dose on specified days
    Other names:
    • BMS-986353
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
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.com
855-907-3286
Clinical.Trials@bms.com