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)

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Erythematosus, Systemic
• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	CC-97540	Specified dose on specified days
DRUG	Fludarabine	Specified dose on specified days
DRUG	Cyclophosphamide	Specified dose on specified days

Timeline

• Start date: 2025-07-14
• Primary completion: 2028-05-17
• Completion: 2032-06-15
• First posted: 2025-06-11
• Last updated: 2026-04-17

Locations

93 sites across 16 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Israel, Italy, Japan, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study