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Clinical Trials in the USA / NCT07123038
Recruiting Observational

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
No
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)

FacilityCityRegionStatus
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

ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa Recruiting
Safety and Efficacy of Soquelitinib in Adults With Hidradenitis Suppurativa Recruiting
A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis Recruiting
A Study to Assess NAV-240 in Adult Participants With Hidradenitis Suppurativa Recruiting
A Study Evaluating BFB759 in Moderate to Severe Hidradenitis Suppurativa Active, not recruiting
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