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

April 15, 2026 updated by: Sonoma Biotherapeutics, Inc.
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Medical Center
        • Contact:
          • Uma Vilas Ayachit
          • Phone Number: 925-860-8966
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02111
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • University of Minnesota
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27708
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Enrolled participants will be determined by the number of subjects participating in the SBT777101-01 and SBT777101-02 studies.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants exposed to SBT777101 Treg cell therapy
Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
Time Frame: 15 years
15 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Persistence of the SBT777101 gene-modified Treg therapeutic
Time Frame: 15 years
15 years
Incidence of replication competent lentivirus (RCL)
Time Frame: 15 years
15 years
Mortality in patients who received a gene-modified Treg therapeutic
Time Frame: 15 years
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonoma Biotherapeutics, Inc.

Investigators

  • Study Director: Sarah Baxter, MD, PhD, Sonoma Biotherapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2025

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

August 7, 2025

First Submitted That Met QC Criteria

August 7, 2025

First Posted (Actual)

August 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBT0000-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis (RA)

Clinical Trials on Long Term Safety Monitoring Procedures

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe