Clinical Trial

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)

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-04
notable Trial sites reduced: 104 -> 93 locations 2026-04-18
Trial Details
NCT Number NCT07015983
Lead Sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Conditions Lupus Erythematosus, Systemic, Lupus Nephritis
Enrollment 89 participants
Start Date 2025-07-14
Primary Completion 2028-05-17 (estimated)
Study Completion 2032-06-15 (estimated)
Updated on ClinicalTrials.gov 2026-08-03