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CC-97540 (Zola-cel) for Active Systemic Lupus Erythematosus (SLE)

This study is testing a treatment called CC-97540 (also known as BMS-986353 or Zola-cel), which uses special CD19-targeted NEX-T CAR T cells, for people with active systemic lupus erythematosus (SLE) and lupus nephritis. This is for individuals whose condition hasn't improved enough with glucocorticoids and at least two other immunosuppressant medications. The study aims to see how well CC-97540 works, if it's safe, and how it moves through the body. Success in this study means participants achieve a specific definition of remission (DORIS remission) without needing their usual lupus medications after 6 months. The current status of this study is unclear, and it plans to enroll 89 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 89 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at month 6, indicating follow-up for at least this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07015983

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)

Active, Not Recruiting
PHASE2Ages 16+InterventionalTreatment
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
~89 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:CC-97540FludarabineCyclophosphamide

At a glance

Recruiting sites
0 of 97 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission
Measured over At month 6

Conditions

Lupus Erythematosus, Systemic
Lupus Nephritis

Explore related trials

Lupus GlomerulonephritisSystemic Lupus ErythematosusCD19 Gene

Where it's being run

97 sites across 54 states
New York8
Florida6
California4
Germany4
Japan4
Georgia3
Texas3
Spain3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Proportion of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remissionAt month 6