Phase
Condition
Neuropathy
Polymyositis (Inflammatory Muscle Disease)
Multiple Sclerosis
Treatment
Cyclophosphamide
Fludarabine
CC-97540
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
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.
Study Design
Connect with a study center
Antwerp University Hospital
Edegem, Antwerpen 2650
BelgiumSite Not Available
Local Institution - 0040
Edegem, Antwerpen 2650
BelgiumSite Not Available
Antwerp University Hospital
Edegem 2799007, Antwerpen 2650
BelgiumActive - Recruiting
Local Institution - 0017
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent
Ghent 2797656, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord 59000
FranceSite Not Available
Local Institution - 0027
Lille, Nord 59000
FranceSite Not Available
Hopital Claude Huriez - CHU de Lille
Lille 2998324, Nord 59000
FranceActive - Recruiting
Local Institution - 0012
Lille, Nord-Pas-de-Calais 59037
FranceSite Not Available
Local Institution - 0013
Paris, Ville De Paris 75013
FranceSite Not Available
Pitie Salpetriere University Hospital
Paris, Ville De Paris 75013
FranceSite Not Available
Pitie Salpetriere University Hospital
Paris 2988507, Ville de Paris 75013
FranceActive - Recruiting
Universitaetsklinikum Essen
Essen, Nordrhein-Westfalen 45147
GermanySite Not Available
Local Institution - 0014
Essen 2928810, North Rhine-Westphalia 2861876 45147
GermanySite Not Available
Universitaetsklinikum Essen
Essen 2928810, North Rhine-Westphalia 2861876 45147
GermanyActive - Recruiting
Universitaetsklinikum Magdeburg
Magdeburg 2874545, Saxony-Anhalt 2842565 39120
GermanyActive - Recruiting
Local Institution - 0033
Düsseldorf, 40225
GermanySite Not Available
Local Institution - 0036
Düsseldorf, 40225
GermanySite Not Available
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
GermanySite Not Available
Local Institution - 0033
Düsseldorf 2934246, 40225
GermanyCompleted
Universitaetsklinikum Duesseldorf
Düsseldorf 2934246, 40225
GermanyActive - Recruiting
Local Institution - 0022
Erlangen, 91054
GermanySite Not Available
Universitaetsklinikum Erlangen
Erlangen, 91054
GermanySite Not Available
Universitaetsklinikum Erlangen
Erlangen 2929567, 91054
GermanyActive - Recruiting
Local Institution - 0014
Essen, 45122
GermanySite Not Available
Klinikum der Universität München Großhadern
München, 81337
GermanySite Not Available
Local Institution - 0024
München, 81337
GermanySite Not Available
Klinikum der Universität München Großhadern
München 2867711, 81337
GermanyActive - Recruiting
Local Institution - 0008
Milano, Lombardia 20132
ItalySite Not Available
Local Institution - 0008
Milan 3173435, Lombardy 3174618 20132
ItalySite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0016
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0034
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona 3128760, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Local Institution - 0016
Barcelona 3128760, Barcelona [Barcelona] 08035
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña] 08036
SpainActive - Recruiting
Local Institution - 0026
Barcelona, Catalunya [Cataluña] 08036
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona 3128760, Catalunya [Cataluña] 08036
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Local Institution - 0015
Madrid, Madrid, Comunidad De 28034
SpainSite Not Available
Hospital Universitario Ramón y Cajal
Madrid 3117735, Madrid, Comunidad de 28034
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
Valencia 2509954, 46026
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe
València, 46026
SpainSite Not Available
Local Institution - 0019
València, 46026
SpainSite Not Available
Manchester Royal Infirmary
Manchester, Lancashire M20 2RZ
United KingdomSite Not Available
Manchester Royal Infirmary
Manchester 2643123, Lancashire M20 2RZ
United KingdomActive - Recruiting
Local Institution - 0031
London, London, City Of NW1 2PG
United KingdomSite Not Available
University College London Hospital
London, London, City Of NW1 2PG
United KingdomActive - Recruiting
University College London Hospital
London 2643743, London, City of NW1 2PG
United KingdomActive - Recruiting
Local Institution - 0041
Salford, Manchester M6 8HD
United KingdomSite Not Available
Salford Royal Hospital
Salford, Manchester M6 8HD
United KingdomSite Not Available
Salford Royal Hospital
Salford 2638671, Manchester M6 8HD
United KingdomActive - Recruiting
Barts Health NHS Trust
London, E1 1RD
United KingdomSite Not Available
Local Institution - 0020
London, E1 1RD
United KingdomSite Not Available
Barts Health NHS Trust
London 2643743, E1 1RD
United KingdomActive - Recruiting
Local Institution - 0018
Manchester, M13 9WL
United KingdomSite Not Available
Local Institution - 0011
Birmingham, Alabama 35294
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
United StatesActive - Recruiting
Local Institution - 0028
Irvine, California 92697
United StatesSite Not Available
University of California, Irvine
Irvine, California 92697
United StatesSite Not Available
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
University of California, Irvine
Irvine 5359777, California 5332921 92697
United StatesActive - Recruiting
Local Institution - 0023
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
Colorado Blood Cancer Institute
Denver, Colorado 80218
United StatesSite Not Available
Local Institution - 0035
Denver, Colorado 80218
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Colorado Blood Cancer Institute
Denver 5419384, Colorado 5417618 80218
United StatesActive - Recruiting
Local Institution - 0032
New Haven, Connecticut 06510
United StatesSite Not Available
Yale-New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Yale-New Haven Hospital
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
Local Institution - 0003
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesActive - Recruiting
Local Institution - 0039
New Orleans, Louisiana 70121
United StatesSite Not Available
Local Institution - 0039
New Orleans 4335045, Louisiana 4331987 70121
United StatesSite Not Available
Local Institution - 0005
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02215
United StatesSite Not Available
Local Institution - 0005
Boston 4930956, Massachusetts 6254926 02114
United StatesCompleted
Local Institution - 0004
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Local Institution - 0029
Hackensack, New Jersey 07601
United StatesSite Not Available
Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Local Institution - 0009
New York, New York 10032
United StatesSite Not Available
Local Institution - 0042
New York, New York 10029
United StatesSite Not Available
NYU Langone Ambulatory Care Center
New York, New York 10016
United StatesSite Not Available
Neurological Institute of New York
New York, New York 10032
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Neurological Institute of New York
New York 5128581, New York 5128638 10032
United StatesActive - Recruiting
Local Institution - 0038
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Cleveland Clinic Mellen Center
Cleveland, Ohio 44195
United StatesSite Not Available
Local Institution - 0001
Cleveland, Ohio 44195
United StatesSite Not Available
Local Institution - 0043
Cleveland, Ohio 44195
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
Cleveland Clinic Mellen Center
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
Local Institution - 0037
Portland, Oregon 97239
United StatesSite Not Available
Local Institution - 0037
Portland 5746545, Oregon 5744337 97239
United StatesSite Not Available
Oregon Health and Science University
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Local Institution - 0021
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Local Institution - 0006
Dallas, Texas 75390
United StatesSite Not Available
Local Institution - 0007
Seattle, Washington 98122
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98122
United StatesSite Not Available
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
United StatesActive - Recruiting
Local Institution - 0002
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesActive - Recruiting

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