RECRUITING

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

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.

Conditions

Lupus Erythematosus, SystemicLupus Nephritis
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Related Conditions:

Lupus Erythematosus, SystemicLupus Nephritis

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Lupus Erythematosus, Systemic
Intervention / Treatment

-

Contacts and Locations

Birmingham

Local Institution - 0009, Birmingham, Alabama, United States, 35294-3300

Los Angeles

Local Institution - 0038, Los Angeles, California, United States, 90027

Los Angeles

Local Institution - 0051, Los Angeles, California, United States, 90095

Palo Alto

Local Institution - 0035, Palo Alto, California, United States, 94304

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Jacksonville

Local Institution - 0006, Jacksonville, Florida, United States, 32224

Miami

Local Institution - 0002, Miami, Florida, United States, 33136

Tampa

Local Institution - 0008, Tampa, Florida, United States, 33612

Tampa

Local Institution - 0036, Tampa, Florida, United States, 33612

Zephyrhills

Local Institution - 0062, Zephyrhills, Florida, United States, 33542

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

16 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2032-06-15