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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05869955
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 270 participants
Conditions and interventions
Conditions
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 13, 2023 (Actual)
- Primary completion
- Aug 29, 2028 (Estimated)
- Completion
- Aug 29, 2028 (Estimated)
- Last update posted
- Aug 3, 2026
2023 – 2028
United States locations
- U.S. sites
- 25
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0035 | Aurora | Colorado | 80045 | — |
| Local Institution - 0024 | Denver | Colorado | 80218 | — |
| Local Institution - 0006 | Jacksonville | Florida | 32224 | — |
| Local Institution - 0056 | Miami | Florida | 33136 | — |
| Local Institution - 0053 | Chicago | Illinois | 60612 | — |
| Local Institution - 0038 | Boston | Massachusetts | 02115 | — |
| Local Institution - 0033 | Worcester | Massachusetts | 01655 | — |
| University of Massachusetts Chan Medical School | Worcester | Massachusetts | 01655 | — |
| Local Institution - 0031 | Ann Arbor | Michigan | 48109-2800 | — |
| Local Institution - 0037 | Detroit | Michigan | 48202 | — |
| Local Institution - 0022 | Rochester | Minnesota | 55905 | — |
| Local Institution - 0010 | St Louis | Missouri | 63110 | — |
| Local Institution - 0028 | Omaha | Nebraska | 68198 | — |
| Local Institution - 0008 | Summit | New Jersey | 07901 | — |
| Local Institution - 0002 | New York | New York | 10016 | — |
| Local Institution - 0011 | New York | New York | 10029 | — |
| Local Institution - 0007 | New York | New York | 10032 | — |
| Local Institution - 0003 | Chapel Hill | North Carolina | 27599 | — |
| Local Institution - 0005 | Cleveland | Ohio | 44195 | — |
| Local Institution - 0036 | Dallas | Texas | 75390 | — |
| Local Institution - 0029 | Houston | Texas | 77030 | — |
| Local Institution - 0034 | Houston | Texas | 77030 | — |
| Local Institution - 0004 | Seattle | Washington | 98104 | — |
| Local Institution - 0057 | Seattle | Washington | 98105 | — |
| Local Institution - 0058 | Seattle | Washington | 98109 | — |
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 21 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 Aug 3, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05869955 live on ClinicalTrials.gov.