NCT07123038Recruiting
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 36 (estimated)
- First submitted
- 7 Aug 2025
- Start date
- 22 Jul 2025
- Primary completion date
- Dec 2040
- Lead sponsor
- Sonoma Biotherapeutics, Inc.
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07123038
What you commit to
- Study type: Observational
- Planned participants: 36
- From 22 Jul 2025 to the primary completion date, Dec 2040
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Participation in the study is not in the subject's best interest, in the opinion of the Investigator
Who the study is looking for
- Subject was previously administered at least 1 dose of a Sonoma Biotherapeutics, Inc. gene-modified Treg therapeutic in a prior parent treatment protocol.
- Subject understands the purpose and risks of the study and is willing to provide written informed consent.
- Subject is willing to comply with all study procedures for the follow-up period.
Age in the registry: 18 years to 71 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Tufts University Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Not yet recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Not yet recruiting |
| UCSF Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Stanford Medical Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.