RECRUITINGOBSERVATIONAL
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
About This Trial
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form.
- Subject is willing to comply with all study procedures for the follow-up period.
Who Should NOT Join This Trial:
- Participation in the study is not in the subject's best interest, in the opinion of the Investigator
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
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