What is CC-97540 studying for systemic lupus erythematosus (SLE)?

CC-97540 is being studied to see how it works in people with active SLE, including lupus nephritis, who have not responded well to standard treatments. Researchers want to evaluate its safety, effectiveness, and how the drug behaves in the body. This study is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

Who may be eligible for this systemic lupus erythematosus clinical trial?

People aged 16 and older with active SLE who meet specific diagnostic criteria and have not responded adequately to glucocorticoids and at least two immunosuppressants may be eligible. Both males and females can participate. Certain health conditions, prior therapies like CAR T cell treatment, and pregnancy status may affect eligibility. Please review eligibility criteria for more details.

Is there any cost to participate in this systemic lupus erythematosus clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to and from study visits may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 16Years +

All Genders

ID07015983

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

Led by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Updated on 2026-06-01

Participants Needed

Research Sites

212 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the drug CC-97540 in people aged 16 and older who have active systemic lupus erythematosus SLE, including lupus nephritis, and who have not responded well to glucocorticoids and at least two immunosuppressant treatments. This Phase 2 study aims to assess the effectiveness, safety, and drug levels of CC-97540 in this group. The study is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Participants will receive CC-97540, a type of CD19-targeted NEX-T CAR T cell therapy, along with specified doses of fludarabine and cyclophosphamide on scheduled days. The study is open-label and multicenter, meaning both participants and researchers know which treatment is given. The treatments are designed to evaluate disease control and remission in participants with inadequate prior responses. The study includes multiple assessments over a period of up to 60 months to monitor various health outcomes. Throughout the study, participants will be closely monitored with regular assessments, including measuring drug-free remission rates, kidney response in lupus nephritis cases, disease activity, and patient-reported outcomes like fatigue and pain. Laboratory tests will track kidney function, autoantibody levels, and immune system markers. Safety is carefully observed by recording adverse events and lab abnormalities. The total participation duration can last up to 60 months, allowing thorough evaluation of long-term effects and disease status.

CONDITIONS

Brief Title

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)

Who Can Participate

Age: 16Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants must meet EULAR/ACR 2019 criteria for systemic lupus erythematosus (SLE).
Participants must have an inadequate response to appropriate doses of glucocorticoids and at least 2 immunosuppressant therapies, used for at least 3 months.
Participants must have active disease at the time of consent.

You will not qualify if you...

Participants with other diseases, conditions, or treatments that could affect study results.
Participants with uncontrolled or significant cardiovascular or central nervous system conditions.
Participants with a history of malignancies or lymphoproliferative disease unless disease-free for at least 2 years, except certain non-invasive cancers.
Pregnant or breastfeeding individuals, or those planning pregnancy.
Participants with prior CAR T cell therapy, genetically modified T cell therapy, stem cell transplant, or organ transplant.
Participants who received live vaccines within 6 weeks before lymphodepleting chemotherapy.
Participants with inadequate organ function.
Other protocol-defined criteria may apply.

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here