A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 71
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
UCSF Medical Center
RECRUITING
San Francisco
Stanford Medical Center
RECRUITING
Stanford
Colorado
University of Colorado
RECRUITING
Aurora
Illinois
Northwestern University
RECRUITING
Chicago
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Tufts University
RECRUITING
Boston
Minnesota
University of Minnesota
NOT_YET_RECRUITING
Minneapolis
North Carolina
Duke University
NOT_YET_RECRUITING
Durham
Texas
The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Sabrina Fox-Bosetti, MPH
clinicaloperations@sonomabio.com
415-992-6245
Backup
Jason Do
clinicaloperations@sonomabio.com
415-992-6245
Time Frame
Start Date: 2025-07-22
Estimated Completion Date: 2040-12
Participants
Target number of participants: 36
Treatments
Participants exposed to SBT777101 Treg cell therapy
Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)
Related Therapeutic Areas
Sponsors
Leads: Sonoma Biotherapeutics, Inc.