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)
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)
🩺 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: Review the eligibility criteria below.
Location: Local Institution - 0106 — Phoenix, Arizona
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (97 Sites)
Showing the first 25 of 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.
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- A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus — Huntington Park, California
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Explore by condition: All Lupus Erythematosus, Systemic clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.