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

NCT07123038 · tracked via the Priya Life Science USA tracker

Sponsor

Sonoma Biotherapeutics, Inc.

Phase

Observational

Started

2025-07-22

Last updated

2026-04-16

Condition(s) studied

Rheumatoid Arthritis (RA)Hidradenitis Suppurativa (HS)

Investigational drug(s) / intervention(s)

Long Term Safety Monitoring Procedures

Long 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.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

71 Years

Healthy volunteers

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

Primary outcome measure(s)

Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic — 15 years

Trial sites (10)

Facility	City	Region	Status
UCSF Medical Center	San Francisco	California	Recruiting
Stanford Medical Center	Stanford	California	Recruiting
University of Colorado	Aurora	Colorado	Recruiting
Northwestern University	Chicago	Illinois	Recruiting
Tufts University	Boston	Massachusetts	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
University of Minnesota	Minneapolis	Minnesota	Not Yet Recruiting
Duke University	Durham	North Carolina	Not Yet Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	Not Yet Recruiting

More Sonoma Biotherapeutics, Inc. trials in the USA

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa Active, not recruiting

Study of Single Doses of SBT777101 in Subjects With Rheumatoid Arthritis Recruiting

Other trials for the same condition

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Recruiting

A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101 Recruiting

Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense Active, not recruiting

A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis Recruiting

Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07123038 on ClinicalTrials.gov ↗ ← All trials in the USA