A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Recruiting · NCT07123038 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sonoma Biotherapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Long Term Safety Monitoring Procedures
What this trial is about
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Who can take part
Age range
18 Years to 71 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Participation in the study is not in the subject's best interest, in the opinion of the Investigator
Where it is running
10 locations listed across 7 US states.
- 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