A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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.
Eligibility
- Age range
- 16+ years
- Sex
- All
- Healthy volunteers
- No
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 lymph…
Interventions
- DrugCC-97540
Specified dose on specified days
- DrugFludarabine
Specified dose on specified days
- DrugCyclophosphamide
Specified dose on specified days
Locations (93)
- Local Institution - 0106Scottsdale, Arizona
- Local Institution - 0038Los Angeles, California
- Local Institution - 0051Los Angeles, California
- Local Institution - 0093Newport Beach, California
- Lucile Packard Children's HospitalPalo Alto, California
- University of Colorado Anschutz Medical CampusAurora, Colorado