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NCT07123038 | RECRUITING | Rheumatoid Arthritis (RA)

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

Condition or disease

Rheumatoid Arthritis (RA)

Hidradenitis suppurativa (HS)

Intervention/treatment

Long Term Safety Monitoring Procedures

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
Estimated Enrollment : 36 participants
Official Title : A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Actual Study Start Date : 2025-07-22
Estimated Primary Completion Date : 2040-12
Estimated Study Completion Date : 2040-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 71 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

Location Details

NCT07123038

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

UCSF Medical Center

San Francisco, California, United States, 94143

RECRUITING

United States, California

Stanford Medical Center

Stanford, California, United States, 94305

RECRUITING

United States, Colorado

University of Colorado

Aurora, Colorado, United States, 80045

RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Massachusetts

Tufts University

Boston, Massachusetts, United States, 02111

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

NOT YET RECRUITING

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

NOT YET RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27708

NOT YET RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030