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

Plain Language Summary

Simplified for easier understanding

This is a long-term safety follow-up study for people who previously received an experimental gene-modified immune cell therapy (called a Treg therapy) developed by Sonoma Biotherapeutics. Researchers will monitor participants' health over time to check for any long-term safety concerns. **You may be eligible if...** - You previously received at least one dose of a Sonoma Biotherapeutics gene-modified Treg therapy in a prior clinical study - You are willing to provide informed consent and return for long-term follow-up visits **You may NOT be eligible if...** - You never participated in a prior Sonoma Biotherapeutics treatment study - You are unable or unwilling to provide consent or attend follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.