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Long-Term Safety of Gene-Modified Treg Therapeutic (SBT777101)

This is an observational study looking at the long-term safety of a gene-modified regulatory T cell (Treg) therapeutic called SBT777101. This study is for people who have already received SBT777101 in a previous clinical trial for conditions like Rheumatoid Arthritis (RA) or Hidradenitis Suppurativa (HS). The main goal is to see if any delayed side effects (adverse events) happen up to 15 years after receiving the treatment. You can join if you are between 18 and 71 years old, have previously received SBT777101, understand the study, and are willing to follow the study procedures. The study is currently unclear on its recruitment status.

Study design
This is an observational study with a planned enrollment of 36 participants. It is a Phase 4 study, meaning it looks at long-term safety after a treatment has been initially studied.
What's involved
Participants will complete long-term safety and health questionnaires, have routine physical examinations, and undergo reviews of selected adverse events, medical history, and medication use.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 15 years after receiving the gene-modified Treg therapeutic in prior studies.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07123038

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

Recruiting
Not specifiedAges 18–71Observational
Sonoma Biotherapeutics, Inc.
~36 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Long Term Safety Monitoring Procedures

At a glance

Recruiting sites
7 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
Measured over 15 years

Conditions

Rheumatoid Arthritis (RA)
Hidradenitis Suppurativa (HS)

Explore related trials

Hidradenitis SuppurativaRheumatoid Arthritis

Where it's being run

10 sites across 7 states
Massachusetts3
California2
Colorado1
Illinois1
Minnesota1
North Carolina1
Texas1

Study leadership

  • Sarah Baxter, MD, PhD · STUDY_DIRECTOR · Sonoma Biotherapeutics

Who to contact

Sabrina Fox-Bosetti, MPH
[email protected]
415-992-6245
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Participation in the study is not in the subject's best interest, in the opinion of the Investigator

What this trial measures

  • Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic15 years