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Purpose

The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.

Conditions

Eligibility

Eligible Ages
Over 16 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants must meet EULAR/ACR 2019 criteria for SLE. - Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. - Participants must have active disease when signing ICF.

Exclusion Criteria

  • Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE. - Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies. - IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study. - Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, or stem cell transplant. Washout periods may be required. - Participants must not have received live vaccines within 6 weeks before CC-97540 administration. - Participant must not have inadequate organ function. - Other protocol defined inclusion/exclusion criteria apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Administration of CC-97540
  • Drug: CC-97540
    Specified dose on specified days
    Other names:
    • BMS-986353
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days

Recruiting Locations

Lucile Packard Children's Hospital
Palo Alto 5380748, California 5332921 94304
Contact:
Jessie Alexander, Site 0035
650-497-8953

University of Colorado Anschutz Medical Campus
Aurora 5412347, Colorado 5417618 80045
Contact:
Melissa Griffith, Site 0033
720-848-7700

Mayo Clinic in Florida
Jacksonville 4160021, Florida 4155751 32224
Contact:
Vikas Majithia, Site 0006
904-953-2000

Moffitt Cancer Center
Tampa 4174757, Florida 4155751 33612
Contact:
SAYEEF MIRZA, Site 0036
813-745-5694

USF Health
Tampa 4174757, Florida 4155751 33612
Contact:
Loutfi Succari, Site 0008
813-974-2681

Florida Medical Clinic Orlando Health
Zephyrhills 4178941, Florida 4155751 33542
Contact:
Julio Gonzalez-Paoli, Site 0062
787-529-5488

Atlantic Health System Overlook Medical Center
Summit 5105127, New Jersey 5101760 07901
Contact:
Neil Kramer, Site 0001
646-734-2774

Hospital for Special Surgery
New York 5128581, New York 5128638 10021
Contact:
Kyriakos Kirou, Site 0040
212-606-1728

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Margrit Wiesendanger, Site 0004
646-285-7881

Weill Cornell Medical College
New York 5128581, New York 5128638 10065
Contact:
Caitlin Gribbin, Site 0039

Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418 45229
Contact:
Hermine Brunner, Site 0012
513-636-7982

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Emily Littlejohn, Site 0003
216-445-5559

Baylor Scott and White Research Institute
Dallas 4684888, Texas 4736286 75246
Contact:
Ankit Mehta, Site 0059
214-370-1000

Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
Contact:
Philip Mease, Site 0007
206-386-2000

More Details

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

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
8559073286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.