A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Public ClinicalTrials.gov record NCT05869955. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Study identification
- NCT ID
- NCT05869955
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Industry
- Enrollment
- 270 participants
Conditions and interventions
Conditions
Interventions
- CC-97540 Drug
- Cyclophosphamide Drug
- Fludarabine Drug
- Tocilizumab Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2023
- Primary completion
- Aug 28, 2028
- Completion
- Aug 28, 2028
- Last update posted
- May 3, 2026
2023 – 2028
United States locations
- U.S. sites
- 30
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | Recruiting |
| Local Institution - 0048 | New Haven | Connecticut | 06520 | Withdrawn |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | 33136 | Recruiting |
| Local Institution - 0053 | Chicago | Illinois | 60612 | Active, not recruiting |
| Local Institution - 0030 | Baltimore | Maryland | 21287 | Withdrawn |
| Local Institution - 0038 | Boston | Massachusetts | 02115 | Not yet recruiting |
| Local Institution - 0046 | Boston | Massachusetts | 02115 | Withdrawn |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109-2800 | Recruiting |
| Henry Ford Medical Center - New Center One | Detroit | Michigan | 48202 | Recruiting |
| Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota | 55905 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Local Institution - 0028 | Omaha | Nebraska | 68198 | Completed |
| Atlantic Health System Overlook Medical Center | Summit | New Jersey | 07901 | Recruiting |
| NYU Langone Health | New York | New York | 10016 | Recruiting |
| Local Institution - 0054 | New York | New York | 10021 | Withdrawn |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| Columbia University Irving Medical Center | New York | New York | 10032 | Recruiting |
| Local Institution - 0055 | New York | New York | 10065 | Withdrawn |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Local Institution - 0027 | Columbus | Ohio | 43203 | Withdrawn |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Swedish Medical Center | Seattle | Washington | 98104 | Recruiting |
| Local Institution - 0057 | Seattle | Washington | 98105 | Not yet recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05869955, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 3, 2026 · Synced May 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05869955 live on ClinicalTrials.gov.