🏛️ Verified NIH Record • Updated 2026-07-31
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) (NCT07015983)
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (8 items).
Location: Local Institution - 0106 — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE.
- Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies.
- IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant.
- Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant.
- Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration.
- Participant must not have inadequate organ function.
- Other protocol-defined inclusion/exclusion criteria apply.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (97 Sites)
- Local Institution - 0106 — Phoenix, Arizona
- Local Institution - 0038 — Los Angeles, California
- Local Institution - 0051 — Los Angeles, California
- Local Institution - 0093 — Newport Beach, California
- Lucile Packard Children's Hospital — Palo Alto, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Colorado Blood Cancer Institute — Denver, Colorado
- Mayo Clinic in Florida — Jacksonville, Florida
- University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami, Florida
- Local Institution - 0073 — Orlando, Florida
- Moffitt Cancer Center — Tampa, Florida
- USF Health — Tampa, Florida
- Florida Medical Clinic Orlando Health — Zephyrhills, Florida
- Emory University School of Medicine — Atlanta, Georgia
- Local Institution - 0079 — Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia
- Local Institution - 0108 — Indianapolis, Indiana
- Local Institution - 0086 — Baton Rouge, Louisiana
- Local Institution - 0110 — Shreveport, Louisiana
- Local Institution - 0094 — Boston, Massachusetts
- Local Institution - 0096 — Ann Arbor, Michigan
- Local Institution - 0011 — Rochester, Minnesota
- Atlantic Health System Overlook Medical Center — Summit, New Jersey
- Local Institution - 0101 — Manhasset, New York
- Local Institution - 0082 — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.