Phase
Condition
Lupus
Kidney Disease
Nephritis
Treatment
Fludarabine
Cyclophosphamide
CC-97540
Clinical Study ID
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria
Participants must meet EULAR/ACR 2019 criteria for SLE.
Participants must have an inadequate response to appropriate doses ofglucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months.
Participants must have active disease when signing ICF.
Exclusion
Key Exclusion Criteria:
Participants must not have other diseases, conditions, or treatments that mayconfound interpretation of the effects of CC-97540 in SLE.
Uncontrolled or clinically significant cardiovascular conditions or CNS pathologyparticipants must not have prior history of malignancies or lymphoproliferativedisease, unless the participant has been free of the disease for ≥ 2 years, exceptfor some non-invasive malignancies.
IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnantduring participation in the study.
Participants must not have prior treatment with CAR T cell therapy, geneticallymodified T cell therapy, or stem cell transplant. Washout periods may be required.
Participants must not have received live vaccines within 6 weeks before CC-97540administration.
Participant must not have inadequate organ function.
Other protocol defined inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Local Institution - 0016
ABB, Buenos Aires F.D. 3433955 C1199ABB
ArgentinaSite Not Available
Local Institution - 0017
ABB, Buenos Aires F.D. 3433955 C1199ABB
ArgentinaSite Not Available
Local Institution - 0023
Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1118AAT
ArgentinaSite Not Available
Local Institution - 0023
Buenos Aires, Ciudad Autónoma De Buenos Aires C1118AAT
ArgentinaSite Not Available
Local Institution - 0077
Córdoba 3860259, X5016
ArgentinaSite Not Available
Local Institution - 0037
Vienna 2761369, Vienna 2761367 1090
AustriaSite Not Available
Local Institution - 0037
Vienna, Wien 1090
AustriaSite Not Available
Local Institution - 0031
Salzburg, 5020
AustriaSite Not Available
Local Institution - 0031
Salzburg 2766824, 5020
AustriaSite Not Available
Local Institution - 0020
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
Local Institution - 0020
Leuven 2792482, Vlaams-Brabant 3000
BelgiumSite Not Available
Local Institution - 0058
Sao Paulo, São Paulo 01509-010
BrazilSite Not Available
Local Institution - 0058
São Paulo 3448439, São Paulo 3448433 01509-010
BrazilSite Not Available
Local Institution - 0021
São Paulo, 01409-902
BrazilSite Not Available
Local Institution - 0022
São Paulo, 05652-900
BrazilSite Not Available
Local Institution - 0021
São Paulo 3448439, 01409-902
BrazilSite Not Available
Local Institution - 0022
São Paulo 3448439, 05652-900
BrazilSite Not Available
Local Institution - 0048
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Local Institution - 0048
Vancouver 6173331, British Columbia 5909050 V5Z 1M9
CanadaSite Not Available
Local Institution - 0045
Toronto, Ontario M5G 1X8
CanadaSite Not Available
Local Institution - 0045
Toronto 6167865, Ontario 6093943 M5G 1X8
CanadaSite Not Available
Local Institution - 0056
Odense 2615876, Region Syddanmark 6418542 5000
DenmarkSite Not Available
Local Institution - 0056
Odense, Syddanmark 5000
DenmarkSite Not Available
Local Institution - 0047
Copenhagen, 2100
DenmarkSite Not Available
Local Institution - 0047
Copenhagen 2618425, 2100
DenmarkSite Not Available
Local Institution - 0018
Montpellier, Hérault 34295
FranceSite Not Available
Local Institution - 0018
Montpellier 2992166, Hérault 34295
FranceSite Not Available
Local Institution - 0064
Paris, Île-de-France 75013
FranceSite Not Available
Local Institution - 0064
Paris 2988507, Île-de-France Region 3012874 75013
FranceSite Not Available
Local Institution - 0019
Rennes, 35033
FranceSite Not Available
Local Institution - 0019
Rennes 2983990, 35033
FranceSite Not Available
Local Institution - 0029
Köln, Nordrhein-Westfalen 50937
GermanySite Not Available
Local Institution - 0029
Cologne 2886242, North Rhine-Westphalia 2861876 50937
GermanySite Not Available
Local Institution - 0028
Leipzig, Sachsen 04103
GermanySite Not Available
Local Institution - 0030
Magdeburg, Sachsen-Anhalt 39120
GermanySite Not Available
Local Institution - 0028
Leipzig 2879139, Saxony 2842566 04103
GermanySite Not Available
Local Institution - 0030
Magdeburg 2874545, Saxony-Anhalt 2842565 39120
GermanySite Not Available
Local Institution - 0026
Berlin, 10117
GermanySite Not Available
Local Institution - 0026
Berlin 2950159, 10117
GermanySite Not Available
Local Institution - 0027
Erlangen, 91054
GermanySite Not Available
Local Institution - 0027
Erlangen 2929567, 91054
GermanySite Not Available
Local Institution - 0043
Ramat Gan, Central District 294904 5262100
IsraelSite Not Available
Local Institution - 0042
Jerusalem, 9112001
IsraelSite Not Available
Local Institution - 0042
Jerusalem 281184, 9112001
IsraelSite Not Available
Local Institution - 0025
Roma, Lazio 00168
ItalySite Not Available
Local Institution - 0025
Rome 3169070, Lazio 3174976 00168
ItalySite Not Available
Local Institution - 0032
Milan, Milano 20162
ItalySite Not Available
Local Institution - 0032
Milan 3173435, Milano 20162
ItalySite Not Available
Local Institution - 0044
Rome, Roma 00165
ItalySite Not Available
Local Institution - 0044
Rome 3169070, Roma 00165
ItalySite Not Available
Local Institution - 0070
Pisa, Toscana 56126
ItalySite Not Available
Local Institution - 0070
Pisa 3170647, Tuscany 3165361 56126
ItalySite Not Available
Local Institution - 0055
Sapporo, Hokkaido 0608648
JapanSite Not Available
Local Institution - 0055
Sapporo 2128295, Hokkaido 2130037 0608648
JapanSite Not Available
Local Institution - 0072
Yokohama, Kanagawa 236-0004
JapanSite Not Available
Local Institution - 0072
Yokohama 1848354, Kanagawa 1860291 236-0004
JapanSite Not Available
Local Institution - 0068
Bunkyo-ku, Tokyo 1850144 113-8431
JapanSite Not Available
Local Institution - 0069
Shinjuku-ku, Tokyo 1850144 1608582
JapanSite Not Available
Local Institution - 0067
Chiba, 260-8677
JapanSite Not Available
Local Institution - 0067
Chiba 2113015, 260-8677
JapanSite Not Available
Local Institution - 0054
Fukuoka, 812-8582
JapanSite Not Available
Local Institution - 0054
Fukuoka 1863967, 812-8582
JapanSite Not Available
Local Institution - 0063
Okayama, 700-8558
JapanSite Not Available
Local Institution - 0063
Okayama 1854383, 700-8558
JapanSite Not Available
Local Institution - 0053
Osaka, 545-8586
JapanSite Not Available
Local Institution - 0053
Osaka 1853909, 545-8586
JapanSite Not Available
Local Institution - 0046
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Local Institution - 0046
Amsterdam 2759794, North Holland 2749879 1105 AZ
NetherlandsSite Not Available
Local Institution - 0024
Bytom 3101950, Silesian Voivodeship 3337497 41-902
PolandSite Not Available
Local Institution - 0049
Gliwice 3099230, Silesian Voivodeship 3337497 44-101
PolandSite Not Available
Local Institution - 0034
Łódź, Łódzkie 93-513
PolandSite Not Available
Local Institution - 0034
Lodz 3093133, Łódź Voivodeship 3337493 93-513
PolandSite Not Available
Local Institution - 0024
Bytom, Śląskie 41-902
PolandSite Not Available
Local Institution - 0049
Gliwice, Śląskie 44-101
PolandSite Not Available
Local Institution - 0013
Lisbon, Lisboa 1649-035
PortugalSite Not Available
Local Institution - 0013
Lisbon 2267057, Lisbon District 2267056 1649-035
PortugalSite Not Available
Local Institution - 0015
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0015
Barcelona 3128760, Barcelona [Barcelona] 08035
SpainSite Not Available
Local Institution - 0071
Esplugues de Llobregat, Barcelona [Barcelona] 08950
SpainSite Not Available
Local Institution - 0071
Esplugues de Llobregat 3122826, Barcelona [Barcelona] 08950
SpainSite Not Available
Local Institution - 0014
Málaga, 29011
SpainSite Not Available
Local Institution - 0014
Málaga 2514256, 29011
SpainSite Not Available
Local Institution - 0050
London, London, City Of SE5 9RL
United KingdomSite Not Available
Local Institution - 0057
London, London, City Of W1T 7HA
United KingdomSite Not Available
Local Institution - 0060
London, London, City Of NW1 2PG
United KingdomSite Not Available
Local Institution - 0061
London, London, City Of NW1 2PG
United KingdomSite Not Available
Local Institution - 0050
London 2643743, London, City of SE5 9RL
United KingdomSite Not Available
Local Institution - 0057
London 2643743, London, City of W1T 7HA
United KingdomSite Not Available
Local Institution - 0060
London 2643743, London, City of NW1 2PG
United KingdomSite Not Available
Local Institution - 0061
London 2643743, London, City of NW1 2PG
United KingdomSite Not Available
Local Institution - 0009
Birmingham, Alabama 35294-3300
United StatesSite Not Available
Local Institution - 0009
Birmingham 4049979, Alabama 4829764 35294-3300
United StatesSite Not Available
Local Institution - 0038
Los Angeles, California 90027
United StatesSite Not Available
Local Institution - 0051
Los Angeles, California 90095
United StatesSite Not Available
Local Institution - 0035
Palo Alto, California 94304
United StatesSite Not Available
Local Institution - 0038
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
Local Institution - 0051
Los Angeles 5368361, California 5332921 90095
United StatesSite Not Available
Lucile Packard Children's Hospital
Palo Alto 5380748, California 5332921 94304
United StatesActive - Recruiting
Local Institution - 0033
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Local Institution - 0006
Jacksonville, Florida 32224
United StatesSite Not Available
Mayo Clinic in Florida
Jacksonville, Florida 32224
United StatesSite Not Available
Local Institution - 0002
Miami, Florida 33136
United StatesSite Not Available
Local Institution - 0008
Tampa, Florida 33612
United StatesSite Not Available
Local Institution - 0036
Tampa, Florida 33612
United StatesSite Not Available
Local Institution - 0062
Zephyrhills, Florida 33542
United StatesSite Not Available
Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224
United StatesActive - Recruiting
Local Institution - 0002
Miami 4164138, Florida 4155751 33136
United StatesSite Not Available
Local Institution - 0073
Orlando 4167147, Florida 4155751 32804
United StatesSite Not Available
Local Institution - 0008
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Local Institution - 0036
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Local Institution - 0062
Zephyrhills 4178941, Florida 4155751 33542
United StatesSite Not Available
Local Institution - 0074
Honolulu 5856195, Hawaii 5855797 96813
United StatesSite Not Available
Local Institution - 0052
Boston, Massachusetts 02215
United StatesSite Not Available
Local Institution - 0052
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Local Institution - 0011
Rochester, Minnesota 55905
United StatesSite Not Available
Local Institution - 0011
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Atlantic Health System Overlook Medical Center
Summit, New Jersey 07901
United StatesSite Not Available
Local Institution - 0001
Summit, New Jersey 07901
United StatesSite Not Available
Atlantic Health System Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901
United StatesActive - Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United StatesSite Not Available
Local Institution - 0004
New York, New York 10029
United StatesSite Not Available
Local Institution - 0005
New York, New York 10032
United StatesSite Not Available
Local Institution - 0039
New York, New York 10065
United StatesSite Not Available
Local Institution - 0040
New York, New York 10021
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Local Institution - 0005
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Local Institution - 0039
New York 5128581, New York 5128638 10065
United StatesSite Not Available
Local Institution - 0040
New York 5128581, New York 5128638 10021
United StatesSite Not Available
Local Institution - 0010
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Local Institution - 0065
Charlotte, North Carolina 28211
United StatesSite Not Available
Local Institution - 0010
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesSite Not Available
Local Institution - 0065
Charlotte 4460243, North Carolina 4482348 28211
United StatesSite Not Available
Local Institution - 0012
Cincinnati, Ohio 45229
United StatesSite Not Available
Local Institution - 0003
Cleveland, Ohio 44195
United StatesSite Not Available
Local Institution - 0012
Cincinnati 4508722, Ohio 5165418 45229
United StatesSite Not Available
Local Institution - 0003
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Local Institution - 0041
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Local Institution - 0041
Oklahoma City 4544349, Oklahoma 4544379 73104
United StatesSite Not Available
Baylor Scott and White Research Institute
Dallas, Texas 75246
United StatesSite Not Available
Local Institution - 0059
Dallas, Texas 75246
United StatesSite Not Available
Baylor Scott and White Research Institute
Dallas 4684888, Texas 4736286 75246
United StatesActive - Recruiting
Local Institution - 0007
Seattle, Washington 98122
United StatesSite Not Available
Local Institution - 0007
Seattle 5809844, Washington 5815135 98122
United StatesSite Not Available
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