Summary

Eligibility
for people ages 16 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants

Keywords

Lupus Erythematosus, Systemic, Lupus Nephritis, Lupus, SLE, LN, CAR T, Cell Therapy, CD19 CAR T, CD19, CD19 NEX-T, CD19 NEXT, CD19 NEX T, Nephritis, Systemic Lupus Erythematosus, Cyclophosphamide, Fludarabine, Administration of CC-97540

Eligibility

You can join if…

Open to people ages 16 years and up

  • 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 CAN'T join 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 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.

Locations

  • Local Institution - 0051
    Los Angeles California 90095 United States
  • Local Institution - 0038
    Los Angeles California 90027 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07015983
Phase
Phase 2 Lupus Research Study
Study Type
Interventional
Participants
Expecting 89 study participants
Last Updated