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)
NCT ID: NCT06220201
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
120 participants
INTERVENTIONAL
2024-03-28
2027-07-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of CC-97540 (RMS arm)
CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Administration of CC-97540 (PMS arm)
CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Administration of CC-97540 (MG arm)
CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Interventions
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CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Irvine
Irvine, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale-New Haven Hospital
New Haven, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Local Institution - 0039
New Orleans, Louisiana, United States
Local Institution - 0005
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Neurological Institute of New York
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Mellen Center
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Swedish Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Antwerp University Hospital
Edegem, Antwerpen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Hopital Claude Huriez - CHU de Lille
Lille, Nord, France
Pitie Salpetriere University Hospital
Paris, Ville de Paris, France
Local Institution - 0014
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Local Institution - 0033
Düsseldorf, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Klinikum der Universität München Großhadern
München, , Germany
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0016
Barcelona, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Manchester Royal Infirmary
Manchester, Lancashire, United Kingdom
University College London Hospital
London, London, City of, United Kingdom
Salford Royal Hospital
Salford, Manchester, United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Khurram Bashir, Site 0011
Role: primary
Michael Sy, Site 0028
Role: primary
Amanda Piquet, Site 0023
Role: primary
Richard Nash, Site 0035
Role: primary
Erin Longbrake, Site 0032
Role: primary
Sharon Lynch, Site 0003
Role: primary
Robert Naismith, Site 0004
Role: primary
Krupa Pandey, Site 0029
Role: primary
Fred Lublin, Site 0042
Role: primary
Rebecca Farber, Site 0009
Role: primary
Aram Zabeti, Site 0038
Role: primary
Jeffrey Cohen, Site 0001
Role: primary
Vijayshree Yadav, Site 0037
Role: primary
Pavle Repovic, Site 0007
Role: primary
Ahmed Obeidat, Site 0002
Role: primary
Barbara Willekens, Site 0040
Role: primary
Guy Laureys, Site 0017
Role: primary
Ibrahim YAKOUB-AGHA, Site 0027
Role: primary
Celine Louapre, Site 0013
Role: primary
Dimitrios Mougiakakos, Site 0044
Role: primary
Silvia Spoerl, Site 0022
Role: primary
Tania Kümpfel, Site 0024
Role: primary
Xavier Montalban, Site 0034
Role: primary
Site 0016
Role: primary
Yolanda Blanco, Site 0026
Role: primary
LUCIENNE FRANCA, Site 0015
Role: primary
Bonaventura Casanova, Site 0019
Role: primary
Eleni Tholouli, Site 0018
Role: primary
claire roddie, Site 0031
Role: primary
david rog, Site 0041
Role: primary
Ben Turner, Site 0020
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-507820-22
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1296-8579
Identifier Type: OTHER
Identifier Source: secondary_id
CA061-1006
Identifier Type: -
Identifier Source: org_study_id