Last updated 25 days ago
A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
89 patients around the world
Available in Brazil, Argentina, United States
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
89Patients around the world
This study is for people with
Lupus
Systemic lupus erythematosus
Requirements for the patient
From 16 Years
All Gender
Medical requirements
- 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.
- 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.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.
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study typeInterventional
Conditions
Systemic lupus erythematosus
Requirements
From 16 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07015983
