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Trial ID CA061-1006  |   NCT06220201

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)

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-60
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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).

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Relapsing forms of Multiple Sclerosis (RMS)
    1. Cohort 1.
      1. Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.
        1. 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.
        2. Progressive forms of MS
          1. Cohort 2.
            1. Participants must have an EDSS ≥ 3.0 and ≤ 6.0.
              1. Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).
              2. Myasthenia Gravis
                1. Cohort 3 i)MGFA classification of II-IV at screening
                  1. Documentation of autoantibodies against AChR or MuSK (historical or at Screening)
                    1. Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.
                      1. Has had thymectomy, only if indicated according to current guidelines.

                      Exclusion Criteria

                      Exclusion Criteria Icon
                      • 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.
                        1. Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
                          1. 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.
                            Additional Information *
                            • Other protocol-defined Inclusion/Exclusion criteria apply.

                              Treatment Options

                              Study Arms

                              ASSIGNED INTERVENTION

                              Study Arms

                              Experimental: Administration of CC-97540 (MG arm)

                              ASSIGNED INTERVENTION
                              • Drug: CC-97540, Fludarabine, Cyclophosphamide

                              Study Arms

                              Experimental: Administration of CC-97540 (PMS arm)

                              ASSIGNED INTERVENTION
                              • Drug: CC-97540, Fludarabine, Cyclophosphamide

                              Study Arms

                              Experimental: Administration of CC-97540 (RMS arm)

                              ASSIGNED INTERVENTION
                              • Drug: CC-97540, Fludarabine, Cyclophosphamide

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