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

NCT ID
NCT07123038
Registry status
Recruiting
Study type
Observational
Sponsor
Sonoma Biotherapeutics, Inc.
Conditions
Hidradenitis Suppurativa (HS), Rheumatoid Arthritis (RA)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 36 participants (Estimated).

What is being studied

  • Other: Long Term Safety Monitoring Procedures

Who may be eligible

Ages
18 Years to 71 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility 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

Study locations

10 study locations are listed.

Recruiting site status is explicitly provided for 10 locations; 7 are listed as Recruiting.

Countries: United States

  • California, United States: 2
  • Colorado, United States: 1
  • Illinois, United States: 1
  • Massachusetts, United States: 3
  • Minnesota, United States: 1
  • North Carolina, United States: 1
  • Texas, United States: 1

Sample of listed locations

  • 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
  • Brigham and Women's Hospital — Boston, Massachusetts, 02115, United States — Recruiting
  • Massachusetts General Hospital — Boston, Massachusetts, 02114, United States — Recruiting
  • Tufts University — Boston, Massachusetts, 02111, 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

Study details

Start date
July 22, 2025
Primary completion date
December 1, 2040
Completion date
December 1, 2040
First posted
August 14, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07123038
Registry last updated
April 16, 2026
QualifiedStudies registry data refreshed
October 2, 2026
QualifiedStudies record fetched
October 2, 2026

View NCT07123038 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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