Trials / Recruiting
RecruitingNCT05869955
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
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
- Phase 1
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
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 |
| DRUG | Tocilizumab | Specified dose on specified days |
Timeline
- Start date
- 2023-09-13
- Primary completion
- 2028-08-29
- Completion
- 2028-08-29
- First posted
- 2023-05-23
- Last updated
- 2026-01-13
Locations
54 sites across 6 countries: United States, Belgium, France, Germany, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05869955. Inclusion in this directory is not an endorsement.