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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 or Progressive Forms of Multiple Sclerosis

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-60
    Age Range
  • 31
    Locations
  • BMS Recruiting Study icon
    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) or Progressive Forms of Multiple Sclerosis (PMS).

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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).

              Exclusion Criteria

              Exclusion Criteria Icon
              • Participants that cannot complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
                1. Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
                  1. Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.
                    Additional Information *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Treatment Options

                      Study Arms

                      ASSIGNED INTERVENTION

                      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, Cyclophosphamide, Fludarabine
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