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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 (Jun 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 Jun 2026Location: International · 6 countries

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

Treatments studied

Chemotherapy

FludarabineCyclophosphamide

Other

CC-97540

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)

Demographics

Ages ≤ 60

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 →

Frequently asked questions

Is NCT06220201 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received high-efficacy disease-modifying therapy and immunosuppressant.

Does this trial require CHRNA1?

Yes, CHRNA1 autoantibodies against AChR is a required biomarker for enrollment.

Does this trial require MUSK?

Yes, MUSK autoantibodies against MuSK is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 60 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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