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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)

NCT07015983

Active Not RecruitingPhase 2

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

Conditions: Lupus Erythematosus, Systemic, Lupus Nephritis

Interventions: CC-97540, Fludarabine, Cyclophosphamide

Countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Denmark, France

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 overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.
* 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.

Locations (97)

Phoenix, Arizona, United States
Los Angeles, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Palo Alto, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Rochester, Minnesota, United States
Summit, New Jersey, United States
Manhasset, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
+ 67 more on CT.gov