← Klinické štúdie • Glomerulopatie
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 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)
Nábor prebieha
• Fáza 2 • intervenčná • NCT07015983
Stručný súhrn
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.
Základné údaje
| Ochorenia | Lupus Erythematosus, Systemic, Lupus Nephritis |
|---|---|
| Intervencie |
DRUG: CC-97540 DRUG: Fludarabine DRUG: Cyclophosphamide |
| Sponzor | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company |
| Plánovaný počet | 89 |
| Začiatok | 2025-07-14 |
| Predp. ukončenie (primárne) | 2028-05-17 |
| Krajiny | United States, Argentina, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, United Kingdom |
| Posledná aktualizácia | 2026-06-24 |
Upozornenie: údaje sú orientačné a podliehajú zmenám. Úplné vstupné/vylučovacie
kritériá, kontakty a aktuálny stav nájdete v oficiálnom registri. Tento prehľad
nenahrádza lekársku konzultáciu.