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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
Summary
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).
Official title: A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-03-28
Completion Date
2027-07-15
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
CC-97540
Specified dose on specified days
Fludarabine
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Locations (35)
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
Universitaetsklinikum Essen
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