Clinical Trial

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-04
notable Trial sites reduced: 54 -> 46 locations 2026-08-04
Trial Details
NCT Number NCT05869955
Lead Sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Collaborators: Bristol-Myers Squibb Services Unlimited Company
Conditions Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
Enrollment 270 participants
Start Date 2023-09-13
Primary Completion 2028-08-29 (estimated)
Study Completion 2028-08-29 (estimated)
Updated on ClinicalTrials.gov 2026-08-03