A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

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

  • Lupus Erythematosus, Systemic
  • Lupus Nephritis

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