clinical trial · NCT05869955
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company·phase1·recruiting·n = 270
Systemic Lupus ErythematosusIdiopathic Inflammatory MyopathySystemic SclerosisRheumatoid ArthritisCC-97540FludarabineCyclophosphamideTocilizumab
brief 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).
started
Sep 13, 2023
primary completion
Aug 29, 2028
completion
Aug 29, 2028
last updated
Jan 13, 2026
official title
A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol