Actively Recruiting
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Led by Sonoma Biotherapeutics, Inc. · Updated on 2026-04-16
36
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This long-term follow-up observational study is designed to assess the safety of a gene-modified regulatory T cell (Treg) therapeutic in individuals who have previously received this treatment. It focuses on evaluating the type, severity, and possible causes of delayed adverse events over an extended period. The study enrolls adults aged 18 to 71 who have been treated in earlier clinical trials involving the gene-modified Treg therapy. Participants will undergo safety monitoring procedures including completing health questionnaires, routine physical exams, and reviews of medical history and medication use. Biospecimens such as blood and tissue samples will be collected at scheduled visits to detect any delayed adverse events related to the prior cell therapy. The study is planned to last up to 15 years following the initial dose received in parent treatment protocols. Throughout the study, participants will attend visits according to a set schedule for assessments and monitoring. Researchers will measure the incidence of delayed adverse events possibly linked to the gene-modified Treg therapeutic and track persistence of the therapy, replication competent lentivirus incidence, and mortality. The study's long duration allows careful observation of safety outcomes related to the treatment over time.
CONDITIONS
Brief Title
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previously received at least one dose of a Sonoma Biotherapeutics gene-modified Treg therapeutic in a prior treatment protocol
- Understands the purpose and risks of the study and is willing to provide written informed consent
- Willing to comply with all study procedures during the follow-up period
You will not qualify if you...
- Participation is not in the subject's best interest, as determined by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 15 years
Participants who have previously received a gene-modified regulatory T cell therapeutic are observed for up to 15 years to evaluate safety, including monitoring for delayed adverse events, health status, and collecting biospecimens as appropriate.
Scheduled visits according to the study assessment schedule
Trial Site Locations
Total: 10 locations
1
UCSF Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
2
Stanford Medical Center
Stanford, California, United States, 94305
Actively Recruiting
3
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Tufts University
Boston, Massachusetts, United States, 02111
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
9
Duke University
Durham, North Carolina, United States, 27708
Not Yet Recruiting
10
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
S
Sabrina Fox-Bosetti, MPH
J
Jason Do
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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