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

NCT07123038 | Recruiting DMC FDA Drug

• 1 other identifier: SBT0000-01
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Rheumatoid Arthritis (RA); Hidradenitis Suppurativa (HS)

Keywords

Rheumatoid Arthritis; Long Term Follow Up Study; Treg; SBT0000-01; Hidradenitis Suppurativa; SBT777101; SBT777101-01; SBT777101-02

Outcome Measures

Primary Outcomes (1)

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

  15 years

Secondary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

Long Term Safety Monitoring Procedures 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.

Participants exposed to SBT777101 Treg cell therapy

Eligibility Criteria

• Age: 18 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sonoma Biotherapeutics, Inc.: lead

Study Sites (10)

UCSF Medical Center

San Francisco, California, 94143, United States

RECRUITING

Stanford Medical Center

Stanford, California, 94305, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Tufts University

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

NOT YET RECRUITING

Duke University

Durham, North Carolina, 27708, United States

NOT YET RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Conditions

Arthritis, Rheumatoid; Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Sarah Baxter, MD, PhD

  Sonoma Biotherapeutics

  STUDY DIRECTOR

Central Study Contacts

Sabrina Fox-Bosetti, MPH

CONTACT

415-992-6245; clinicaloperations@sonomabio.com

Jason Do

CONTACT

415-992-6245; clinicaloperations@sonomabio.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)