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

Recruiting

• Conditions: Rheumatoid Arthritis (RA); Hidradenitis Suppurativa (HS)

• Registration Number: NCT07123038
• Lead Sponsor: Sonoma Biotherapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2040-12
• Study Completion: 2040-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic	15 years

Secondary Outcome Measures

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

Trial Locations

Locations (10)

UCSF Medical Center; 🇺🇸 San Francisco, California, United States

Stanford Medical Center; 🇺🇸 Stanford, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Tufts University; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States