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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-22

Study Completion Date

2040-12-31

Brief Summary

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

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Detailed Description

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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

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Rheumatoid Arthritis (RA) Hidradenitis Suppurativa (HS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants exposed to SBT777101 Treg cell therapy

Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)

Long Term Safety Monitoring Procedures

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.