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)
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria \- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:. i) Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE. ii) Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening. \- SLE disease activity:. i) Active disease at screening, with recent ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system). ii) Inadequate response to glucoco…
Interventions
- DrugCC-97540
Specified dose on specified days
- DrugFludarabine
Specified dose on specified days
- DrugCyclophosphamide
Specified dose on specified days
- DrugTocilizumab
Specified dose on specified days
Locations (54)
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Colorado Blood Cancer InstituteDenver, Colorado
- Local Institution - 0048New Haven, Connecticut
- Mayo Clinic in FloridaJacksonville, Florida
- University of Miami Hospital and Clinics, Sylvester Cancer CenterMiami, Florida
- Local Institution - 0053Chicago, Illinois