A Study of CC-97540 (BMS-986353 or Zola-cel), 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, stem cell transplant or organ transplant. - Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) 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
    • Zola-cel
    • Zolacabtagene autoleucel
  • Drug: Fludarabine
    Specified dose on specified days
  • Drug: Cyclophosphamide
    Specified dose on specified days

Recruiting Locations

Lucile Packard Children's Hospital
Palo Alto, California 94304
Contact:
Jessie Alexander, Site 0035
650-497-7533
DL-SLECART@StanfordChildrens.org

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

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

University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida 33136
Contact:
Lazaros Lekakis, Site 0002
305-748-0641

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
SAYEEF MIRZA, Site 0036
813-745-5517

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

Florida Medical Clinic Orlando Health
Zephyrhills, Florida 33542
Contact:
Julio Gonzalez-Paoli, Site 0062
813-780-8368

Emory University School of Medicine
Atlanta, Georgia 30322
Contact:
Arezou Khosroshahi, Site 0078
404-778-6638

Atlantic Health System Overlook Medical Center
Summit, New Jersey 07901
Contact:
Neil Kramer, Site 0001
908-598-7940

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

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

Columbia University Irving Medical Center
New York, New York 10032
Contact:
Anca Askanase, Site 0005
555-555-5555

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

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

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

Baylor Scott and White Research Institute
Dallas, Texas 75246
Contact:
Ankit Mehta, Site 0059
214-820-1530

Swedish Medical Center
Seattle, Washington 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
855-907-3286
Clinical.Trials@bms.com