🏛️ Verified NIH Record • Updated 2026-04-15
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic (NCT07123038)
🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Sonoma Biotherapeutics, Inc.
🩺 Plain-English Summary (8th-Grade Level)
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Who can join: Review the eligibility criteria below.
Location: UCSF Medical Center — San Francisco, California
Age range: 18 Years to 71 Years
🧪 Interventions in This Study
- Long Term Safety Monitoring Procedures (OTHER)
📋 "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 (10 Sites)
- UCSF Medical Center — San Francisco, California
- Stanford Medical Center — Stanford, California
- University of Colorado — Aurora, Colorado
- Northwestern University — Chicago, Illinois
- Tufts University — Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts
- University of Minnesota — Minneapolis, Minnesota
- Duke University — Durham, North Carolina
- The University of Texas MD Anderson Cancer Center — Houston, Texas
📞 Contact the Study Coordinator
Phone: (415) 992-6245
Email: clinicaloperations@sonomabio.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.