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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

RECRUITINGSponsored by Sonoma Biotherapeutics, Inc.
Actively Recruiting
SponsorSonoma Biotherapeutics, Inc.
Started2025-07-22
Est. completion2040-12
Eligibility
Age18 Years – 71 Years
Healthy vol.Accepted
Locations10 sites
View on ClinicalTrials.gov →

NCT07123038

Summary

To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.

Eligibility

Age: 18 Years – 71 YearsHealthy volunteers accepted
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

Conditions3

ArthritisHidradenitis Suppurativa (HS)Rheumatoid Arthritis (RA

Locations10 sites

UCSF Medical Center
San Francisco, California, 94143
Alex Carvidi628-206-2505alexcarvidi@ucsf.edu
Stanford Medical Center
Stanford, California, 94305
Uma Vilas Ayachit925-860-8966
University of Colorado
Aurora, Colorado, 80045
Jennifer Seifert303-724-7541jennifer.seifert@cuanschutz.edu
Northwestern University
Chicago, Illinois, 60611
John Seagrist312-503-0565john.seagrist@northwestern.edu
Tufts University
Boston, Massachusetts, 02111
Andreas Klein617-636-5409tmncccr@tuftsmedicine.org

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