NCT07123038

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: Sonoma Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 71 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.

Conditions

• Rheumatoid Arthritis (RA)
• Hidradenitis Suppurativa (HS)

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-07-22
• Primary completion: 2040-12-01
• Completion: 2040-12-01
• First posted: 2025-08-14
• Last updated: 2026-04-16

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study