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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

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

NCT07015983•Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (102)

Local Institution - 0009

Birmingham, Alabama, United States

Local Institution - 0080

Scottsdale, Arizona, United States

Local Institution - 0106

Scottsdale, Arizona, United States

Local Institution - 0038

Los Angeles, California, United States

Local Institution - 0051

Los Angeles, California, United States

Local Institution - 0093

Newport Beach, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Local Institution - 0105

Denver, Colorado, United States

Local Institution - 0097

Washington D.C., District of Columbia, United States

Key Dates

Start Date

July 14, 2025

Primary Completion Date

May 17, 2028

Completion Date

June 15, 2032

Last Updated

March 17, 2026

Enrollment

ESTIMATED participants

Conditions

Lupus Erythematosus, SystemicLupus Nephritis

Interventions

CC-97540

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

Safety and Efficacy of ONT01 in Lupus