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ACTIVE NOT RECRUITINGPhase1

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)

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

NCT ID: NCT06220201

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
CC-97540 (drug), Fludarabine (drug), Cyclophosphamide (drug)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
CC-97540 — drug: Specified dose on specified days · Fludarabine — drug: Specified dose on specified days · Cyclophosphamide — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 60 Years
Who
All
Number of participants
120
Started
2024-03-28
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple sclerosis
  • • Phase1 - 120 participants
  • • 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)

Who can take part?

  • • Ages 18 Years to 60 Years
  • • Diagnosed with multiple sclerosis

Where?

  • • Manchester - Manchester Royal Infirmary
  • • London - University College London Hospital
  • • Salford - Salford Royal Hospital
  • • London - Barts Health NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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).

Multiple SclerosisMyasthenia Gravis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 60 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ an Expanded Disability Status Scale (EDSS) of ≥ 3
  • ✓ an EDSS ≥ 3

What the study is looking for

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

Where Is This Study? (4 UK sites)

Manchester Royal Infirmary

Manchester M20 2RZ, United Kingdom

Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

University College London Hospital

London NW1 2PG, United Kingdom

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Salford Royal Hospital

Salford M6 8HD, United Kingdom

Barts Health NHS Trust

London E1 1RD, United Kingdom

Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826
Data sourced from ClinicalTrials.gov · Last verified: 2026-07