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A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Sponsor: Sonoma Biotherapeutics, Inc.
Summary
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Key Details
Gender
All
Age Range
18 Years - 71 Years
Study Type
OBSERVATIONAL
Enrollment
36
Start Date
2025-07-22
Completion Date
2040-12
Last Updated
2025-08-14
Healthy Volunteers
No
Interventions
Long Term Safety Monitoring Procedures
In accordance with the schedule of assessments, participants will complete the long term safety and health questionnaire and will undergo routine physical examinations. A review will be conducted on selected adverse events, medical history, and concomitant medication use. Collection of biospecimens (blood and tissue) will be taken as appropriate at scheduled visits to monitor for delayed adverse events related to prior cell therapy.
Locations (10)
UCSF Medical Center
San Francisco, California, United States
Stanford Medical Center
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Tufts University
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Duke University
Durham, North Carolina, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States