clinical trial · NCT07015983
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)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company·phase2·recruiting·n = 89
Lupus Erythematosus, SystemicLupus NephritisCC-97540FludarabineCyclophosphamide
brief 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.
started
Jul 14, 2025
primary completion
May 17, 2028
completion
Jun 15, 2032
last updated
May 8, 2026
official title
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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol