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OncoMatch/Clinical Trials/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)

Is NCT06220201 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CC-97540 and Fludarabine for multiple sclerosis.

Phase 1RecruitingJuno Therapeutics, Inc., a Bristol-Myers Squibb CompanyNCT06220201Data as of May 2026

Treatment: CC-97540 · Fludarabine · Cyclophosphamide — 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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Extracted eligibility criteria

Biomarker criteria

Required: CHRNA1 autoantibodies against AChR

Documentation of autoantibodies against AChR (historical or at Screening)

Required: MUSK autoantibodies against MuSK

Documentation of autoantibodies against MuSK (historical or at Screening)

Prior therapy

Must have received: high-efficacy disease-modifying therapy — at least 6 months

worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months

Must have received: immunosuppressant — at least 2 immunosuppressants, including steroids, NSIs, or biologics

Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama at Birmingham · Birmingham, Alabama
  • University of California, Irvine · Irvine, California
  • University of Colorado Anschutz Medical Campus · Aurora, Colorado
  • Colorado Blood Cancer Institute · Denver, Colorado
  • Yale-New Haven Hospital · New Haven, Connecticut

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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