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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)

Active, Not Recruiting
PHASE1Ages 18–60InterventionalTreatment
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
~120 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:CC-97540FludarabineCyclophosphamide

At a glance

Recruiting sites
0 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to week 104
+6 more outcomes measured

Conditions

Multiple Sclerosis
Myasthenia Gravis

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Where it's being run

34 sites across 28 states
Germany3
Colorado2
New York2
Ohio2
Barcelona [Barcelona]2
Alabama1
California1
Connecticut1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Number of participants with adverse events (AEs)Up to week 104
  • Number of participants with serious adverse events (SAEs)Up to week 104
  • Number of participants with adverse events of special interest (AESIs)Up to week 104
  • Number of participants with laboratory test result abnormalitiesUp to week 104
  • Number of participants with imaging abnormalitiesUp to week 104

    For Cohorts 1 and 2

  • Number of participants with dose-limiting toxicities (DLTs)Up to week 104
  • Recommended Phase 2 dose (RP2D) based on the incidence of DLTs that occur during the DLT evaluation periodUp to week 104