A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Sponsored by Sonoma Biotherapeutics, Inc.
About this study
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.
Where this study is enrolling (10)
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UCSF Medical Center
San Francisco, California
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Stanford Medical Center
Stanford, California
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University of Colorado
Aurora, Colorado
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Northwestern University
Chicago, Illinois
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Massachusetts General Hospital
Boston, Massachusetts
Show all 10 locations
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Brigham and Women's Hospital
Boston, Massachusetts
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Tufts University
Boston, Massachusetts
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University of Minnesota
Minneapolis, Minnesota
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Duke University
Durham, North Carolina
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The University of Texas MD Anderson Cancer Center
Houston, Texas
Who can participate
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
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Trial data sourced from ClinicalTrials.gov.