RECRUITING

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

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Conditions

Lupus Erythematosus, SystemicLupus NephritisLupusSLELNCAR TCell TherapyCD19 CAR TCD19CD19 NEX-TCD19 NEXTCD19 NEX T

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants

Quick Facts

Study Start:2025-07-14
Study Completion:2032-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07015983

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
  2. * 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.
  3. * IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant during participation in the study.
  4. * 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.
  5. * Participants must not have received live vaccines within 6 weeks before CC-97540 administration.
  6. * Participant must not have inadequate organ function.
  7. * Other protocol defined inclusion/exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0009
Birmingham, Alabama, 35294-3300
United States
Local Institution - 0038
Los Angeles, California, 90027
United States
Local Institution - 0051
Los Angeles, California, 90095
United States
Local Institution - 0035
Palo Alto, California, 94304
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Local Institution - 0006
Jacksonville, Florida, 32224
United States
Local Institution - 0002
Miami, Florida, 33136
United States
Local Institution - 0008
Tampa, Florida, 33612
United States
Local Institution - 0036
Tampa, Florida, 33612
United States
Local Institution - 0062
Zephyrhills, Florida, 33542
United States
Local Institution - 0052
Boston, Massachusetts, 02215
United States
Local Institution - 0011
Rochester, Minnesota, 55905
United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901
United States
Local Institution - 0040
New York, New York, 10021
United States
Local Institution - 0004
New York, New York, 10029
United States
Local Institution - 0005
New York, New York, 10032
United States
Local Institution - 0039
New York, New York, 10065
United States
Local Institution - 0010
Chapel Hill, North Carolina, 27599
United States
Local Institution - 0065
Charlotte, North Carolina, 28211
United States
Local Institution - 0012
Cincinnati, Ohio, 45229
United States
Local Institution - 0003
Cleveland, Ohio, 44195
United States
Local Institution - 0041
Oklahoma City, Oklahoma, 73104
United States
Baylor Scott and White Research Institute
Dallas, Texas, 75246
United States
Local Institution - 0007
Seattle, Washington, 98122
United States

Collaborators and Investigators

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

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2032-06-15

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2032-06-15

Terms related to this study

Keywords Provided by Researchers

  • Lupus
  • SLE
  • LN
  • CAR T
  • Cell Therapy
  • CD19 CAR T
  • CD19
  • CD19 NEX-T
  • CD19 NEXT
  • CD19 NEX T

Additional Relevant MeSH Terms

  • Lupus Erythematosus, Systemic
  • Lupus Nephritis