NCT07123038View on ClinicalTrials.gov

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

RecruitingOBSERVATIONAL
Enrollment

36

Participants

Timeline

Start Date

July 22, 2025

Primary Completion Date

December 31, 2040

Study Completion Date

December 31, 2040

Conditions
Rheumatoid Arthritis (RA)Hidradenitis Suppurativa (HS)
Interventions
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.

Trial Locations (10)

27708

NOT_YET_RECRUITING

Duke University, Durham

55455

NOT_YET_RECRUITING

University of Minnesota, Minneapolis

60611

RECRUITING

Northwestern University, Chicago

77030

NOT_YET_RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

80045

RECRUITING

University of Colorado, Aurora

94143

RECRUITING

UCSF Medical Center, San Francisco

94305

RECRUITING

Stanford Medical Center, Stanford

02111

RECRUITING

Tufts University, Boston

02114

RECRUITING

Massachusetts General Hospital, Boston

02115

RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Sonoma Biotherapeutics, Inc.

INDUSTRY

NCT07123038 - A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic | Biotech Hunter | Biotech Hunter