A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

Recruiting now

Conditions studied: Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS)

In brief

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

Key facts

Study ID

NCT07123038

Run by

Sonoma Biotherapeutics, Inc.

People needed

36

Starts

2025-07-22

Expected to finish

2040-12-01

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 71. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participation in the study is not in the subject's best interest, in the opinion of the Investigator

Where it is running

• UCSF Medical Center — San Francisco, California, United States (enrolling)
• Stanford Medical Center — Stanford, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• Tufts University — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• 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

Full record on ClinicalTrials.gov

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