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)

Running, not enrolling · Phase 2

Conditions studied: Lupus Erythematosus, Systemic, Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT07015983

Run by

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

People needed

89

Starts

2025-07-14

Expected to finish

2032-06-15

Last updated by the study team

2026-08-03

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Other protocol-defined inclusion/exclusion criteria apply.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• Columbia University Pediatrics — New York, New York, United States
• Weill Cornell Medical College — New York, New York, United States
• Local Institution - 0111 — Stony Brook, New York, United States
• Carolinas HealthCare System SouthPark — Charlotte, North Carolina, United States
• Local Institution - 0135 — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Local Institution - 0083 — Philadelphia, Pennsylvania, United States
• Baptist Memorial Hospital — Memphis, Tennessee, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States
• Local Institution - 0098 — Dallas, Texas, United States
• Local Institution - 0104 — San Antonio, Texas, United States
• Swedish Medical Center — Seattle, Washington, United States
• Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina
• Hospital Aleman — Buenos Aires, Buenos Aires F.D., Argentina
• Local Institution - 0107 — Buenos Aires, Argentina
• Local Institution - 0077 — Córdoba, Argentina
• Medizinische Universität Wien — Vienna, State of Vienna, Austria
• Uniklinikum Salzburg — Salzburg, Austria
• UZ Leuven — Leuven, Vlaams-Brabant, Belgium
• Local Institution - 0021 — São Paulo, São Paulo, Brazil
• Local Institution - 0058 — São Paulo, São Paulo, Brazil
• Hospital for Special Surgery — New York, New York, United States

Full record on ClinicalTrials.gov

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