A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
Public ClinicalTrials.gov record NCT07015983. 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 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
Study identification
- NCT ID
- NCT07015983
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 89 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 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
- Jul 14, 2025 (Actual)
- Primary completion
- May 17, 2028 (Estimated)
- Completion
- Jun 15, 2032 (Estimated)
- Last update posted
- Aug 3, 2026
2025 – 2032
United States locations
- U.S. sites
- 41
- U.S. states
- 18
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0106 | Phoenix | Arizona | 85054 | — |
| Local Institution - 0038 | Los Angeles | California | 90027 | — |
| Local Institution - 0051 | Los Angeles | California | 90095 | — |
| Local Institution - 0093 | Newport Beach | California | 92663 | — |
| Lucile Packard Children's Hospital | Palo Alto | California | 94304 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | — |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | 33136 | — |
| Local Institution - 0073 | Orlando | Florida | 32803 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| USF Health | Tampa | Florida | 33612 | — |
| Florida Medical Clinic Orlando Health | Zephyrhills | Florida | 33542 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Local Institution - 0079 | Atlanta | Georgia | 30322 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| Local Institution - 0108 | Indianapolis | Indiana | 46250 | — |
| Local Institution - 0086 | Baton Rouge | Louisiana | 70836 | — |
| Local Institution - 0110 | Shreveport | Louisiana | 71101 | — |
| Local Institution - 0094 | Boston | Massachusetts | 02114 | — |
| Local Institution - 0096 | Ann Arbor | Michigan | 48109 | — |
| Local Institution - 0011 | Rochester | Minnesota | 55905 | — |
| Atlantic Health System Overlook Medical Center | Summit | New Jersey | 07901 | — |
| Local Institution - 0101 | Manhasset | New York | 11030 | — |
| Local Institution - 0082 | New York | New York | 10016 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Columbia University Pediatrics | New York | New York | 10032 | — |
| Weill Cornell Medical College | New York | New York | 10065 | — |
| Local Institution - 0111 | Stony Brook | New York | 11794 | — |
| Carolinas HealthCare System SouthPark | Charlotte | North Carolina | 28211 | — |
| Local Institution - 0135 | Winston-Salem | North Carolina | 27106 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Local Institution - 0083 | Philadelphia | Pennsylvania | 19104 | — |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | — |
| Baylor Scott and White Research Institute | Dallas | Texas | 75246 | — |
| Local Institution - 0098 | Dallas | Texas | 75390-9068 | — |
| Local Institution - 0104 | San Antonio | Texas | 78229 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
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 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07015983, 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 NCT07015983 live on ClinicalTrials.gov.