Study of CC-97540 (BMS-986353), CD19-CAR T Cells, in Participants with Active SLE Despite Immunosuppressants (Breakfree-SLE)
Key facts
- Where
- Berlin, Cologne, Erlangen, Herne, Leipzig és Magdeburg, NémetországSee the 6 sites
- Phase
- 2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- University Hospital Cologne AöRCologne, NémetországNo longer taking part
- Universitaetsklinikum Erlangen AöRErlangen, NémetországNo longer taking part
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-RuhrHerne, NémetországNo longer taking part
- Universitaet LeipzigLeipzig, NémetországNo longer taking part
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországNo longer taking part
Trial details
- Who runs it
- Celgene Corp.
- Trial code
- EU 2024-519278-37-00
- Record updated
- 2026. október 16.
- Original description
To evaluate the efficacy of CC-97540 in participants with SLERead full original descriptionShow less
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)
To evaluate the efficacy of CC-97540 in participants with SLE
Inclusion: Be at least 16 years old and must have a body weight of ≥ 40 kg; Have Systemic Lupus Erythematosus (SLE), as defined by the EULAR/ACR 2019 criteria; Have tried glucocorticoids and at least two different immune-suppressing drugs for SLE, for at least three months each, but these treatments didn't work well enough; Have active SLE determined by a scoring system called BILAG (a tool to measure SLE disease activity), and by testing for certain proteins in the blood that are signs of SLE; Have a specific type of kidney disease related to SLE (lupus nephritis [LN]), they must have had a kidney biopsy within the last six months.
Exclusion: Other diseases or conditions, or be receiving treatments, that might make it hard to tell if the study drug, CC-97540, is working; Having had certain types of cell therapies or a stem cell transplant; Having received a live vaccine within six weeks before starting the study drug; Uncontrolled infections; Serious heart conditions; Cancer or a disease where the body makes too many lymphocytes, unless they have been free of the disease for at least two years; Unresolved problems with their central nervous system; Women who are pregnant, nursing, or planning to become pregnant; Poor organ function, as determined by lab tests at the study site.