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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 15 Jan 2026

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At a glance

  • Drugs Zolacaptagene autoleucel (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Myositis; Systemic lupus erythematosus; Systemic scleroderma
  • Focus Adverse reactions
  • Acronyms Breakfree-1
  • Sponsors Bristol-Myers Squibb; Juno Therapeutics

Most Recent Events

  • 25 Oct 2025 According to Bristol Myers Squibb media release, data from systemic sclerosis (SSc), systemic lupus erythematosus (SLE) and idiopathic inflammatory myopathies (IIM) cohorts are being presented at the American College of Rheumatology (ACR) Convergence 2025.
  • 25 Oct 2025 Results (n=71) from systemic sclerosis (SSc), systemic lupus erythematosus (SLE) and idiopathic inflammatory myopathies (IIM) cohorts presented in the Bristol Myers Squibb media release.
  • 13 Aug 2025 Planned number of patients changed from 129 to 270.

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