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

Launched by JUNO THERAPEUTICS, INC., A BRISTOL-MYERS SQUIBB COMPANY · Jun 6, 2025

Keywords

ClinConnect Summary

The Breakfree-SLE clinical trial is studying a new treatment called CC-97540 for people with systemic lupus erythematosus (SLE), particularly those who also have lupus nephritis, which is a serious kidney issue related to lupus. This study aims to see how well CC-97540 works in patients who are still having problems with their lupus despite taking glucocorticoids (a type of steroid) and at least two other medications to suppress the immune system for at least three months.

To be eligible for this trial, participants need to have a confirmed diagnosis of SLE and must not be getting enough relief from their current medications. They should also be experiencing active symptoms when they join the study. However, there are some exclusions; for example, participants should not have other serious health issues or have had certain types of cancer in the past. The trial is not yet recruiting, so those interested will need to wait for it to officially begin. Participants will be monitored closely for safety and how well the treatment is working throughout the study.

Gender

ALL

Eligibility criteria

• • Key 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.
• Key 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, 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.