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)

ClinicalTrials.gov ID: NCT07015983

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.

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ClinicalTrials.gov public records Last synced May 10, 2026, 8:53 AM EDT

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)

Study identification

NCT ID: NCT07015983
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company; Industry
Enrollment: 89 participants

Conditions and interventions

Conditions

Interventions

CC-97540 Drug
Cyclophosphamide Drug
Fludarabine Drug

Drug

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 13, 2025
Primary completion: May 16, 2028
Completion: Jun 14, 2032
Last update posted: May 7, 2026

2025 – 2032

United States locations

U.S. sites: 38
U.S. states: 18
U.S. cities: 29

Facility	City	State	ZIP	Site status
Local Institution - 0106	Scottsdale	Arizona	85259	Not yet recruiting
Local Institution - 0038	Los Angeles	California	90027	Not yet recruiting
Local Institution - 0051	Los Angeles	California	90095	Not yet recruiting
Local Institution - 0093	Newport Beach	California	92658	Not yet recruiting
Lucile Packard Children's Hospital	Palo Alto	California	94304	Recruiting
University of Colorado Anschutz Medical Campus	Aurora	Colorado	80045	Recruiting
Local Institution - 0105	Denver	Colorado	80218	Not yet recruiting
Mayo Clinic in Florida	Jacksonville	Florida	32224	Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center	Miami	Florida	33136	Recruiting
Local Institution - 0073	Orlando	Florida	32803	Not yet recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
USF Health	Tampa	Florida	33612	Recruiting
Florida Medical Clinic Orlando Health	Zephyrhills	Florida	33542	Recruiting
Local Institution - 0076	Athens	Georgia	30606	Not yet recruiting
Emory University School of Medicine	Atlanta	Georgia	30322	Recruiting
Local Institution - 0079	Atlanta	Georgia	30322	Not yet recruiting
Local Institution - 0108	Indianapolis	Indiana	46250	Not yet recruiting
Local Institution - 0086	Baton Rouge	Louisiana	70836	Not yet recruiting
Local Institution - 0094	Boston	Massachusetts	02114	Not yet recruiting
Local Institution - 0096	Ann Arbor	Michigan	48109	Not yet recruiting
Local Institution - 0011	Rochester	Minnesota	55905	Not yet recruiting
Atlantic Health System Overlook Medical Center	Summit	New Jersey	07901	Recruiting
Local Institution - 0101	Manhasset	New York	11030	Not yet recruiting
Local Institution - 0082	New York	New York	10016	Not yet recruiting
Hospital for Special Surgery	New York	New York	10021	Recruiting
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 - 0095	New York	New York	10032	Not yet recruiting
Weill Cornell Medical College	New York	New York	10065	Recruiting
Carolinas HealthCare System SouthPark	Charlotte	North Carolina	28211	Recruiting
Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	45229	Recruiting
Cleveland Clinic	Cleveland	Ohio	44195	Recruiting
Local Institution - 0083	Philadelphia	Pennsylvania	19104	Not yet recruiting
Local Institution - 0092	Memphis	Tennessee	38120	Not yet recruiting
Baylor Scott and White Research Institute	Dallas	Texas	75246	Recruiting
Local Institution - 0098	Dallas	Texas	75390-9068	Not yet recruiting
Local Institution - 0104	San Antonio	Texas	78229	Not yet recruiting
Swedish Medical Center	Seattle	Washington	98122	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 55 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 May 7, 2026 · Synced May 10, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07015983 live on ClinicalTrials.gov.

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