Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
