RecruitingNCT07123038

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

Sponsor

Sonoma Biotherapeutics, Inc.

Enrollment

36 participants

Start Date

Jul 22, 2025

Study Type

OBSERVATIONAL

Conditions

Rheumatoid Arthritis (RA)Hidradenitis Suppurativa (HS)

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 71 Years

Inclusion Criteria3

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 Criteria1

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

Interventions

OTHERLong 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.