A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1) (NCT05869955)
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)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Local Institution - 0035 — Aurora, Colorado
Age range: 18 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 (46 Sites)
Showing the first 25 of 46 sites.
- Local Institution - 0035 — Aurora, Colorado
- Local Institution - 0024 — Denver, Colorado
- Local Institution - 0006 — Jacksonville, Florida
- Local Institution - 0056 — Miami, Florida
- Local Institution - 0053 — Chicago, Illinois
- Local Institution - 0038 — Boston, Massachusetts
- Local Institution - 0033 — Worcester, Massachusetts
- University of Massachusetts Chan Medical School — Worcester, Massachusetts
- Local Institution - 0031 — Ann Arbor, Michigan
- Local Institution - 0037 — Detroit, Michigan
- Local Institution - 0022 — Rochester, Minnesota
- Local Institution - 0010 — St Louis, Missouri
- Local Institution - 0028 — Omaha, Nebraska
- Local Institution - 0008 — Summit, New Jersey
- Local Institution - 0002 — New York, New York
- Local Institution - 0011 — New York, New York
- Local Institution - 0007 — New York, New York
- Local Institution - 0003 — Chapel Hill, North Carolina
- Local Institution - 0005 — Cleveland, Ohio
- Local Institution - 0036 — Dallas, Texas
- Local Institution - 0029 — Houston, Texas
- Local Institution - 0034 — Houston, Texas
- Local Institution - 0004 — Seattle, Washington
- Local Institution - 0057 — Seattle, Washington
- Local Institution - 0058 — Seattle, Washington
💰 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.
More studies in Systemic Lupus Erythematosus
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- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus — Anniston, Alabama
- REACH (Restore Energy, Activity Can Help) Lupus Study — Boston, Massachusetts
- Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus — Birmingham, Alabama
- A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice — Innsbruck, Tyrol
- A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) — Birmingham, Alabama
Explore by condition: All Systemic Lupus Erythematosus 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.