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A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
RecruitingObservational study
Who can join
Ages 18 to 71 · All sexes
Full 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
About the study
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
What is being tested
- Long Term Safety Monitoring Procedures (other)
Sponsor: Sonoma Biotherapeutics, Inc. · Participants: 36 · Started: Jul 22, 2025
Contact the study team
- Sabrina Fox-Bosetti, MPH · Phone: 415-992-6245
- Jason Do · Phone: 415-992-6245
Official record on ClinicalTrials.gov — NCT07123038
Locations in the U.S.
| California | UCSF Medical Center, San Francisco Stanford Medical Center, Stanford |
| Colorado | University of Colorado, Aurora |
| Illinois | Northwestern University, Chicago |
| Massachusetts | Brigham and Women's Hospital, Boston Massachusetts General Hospital, Boston Tufts University, Boston |
| Minnesota | University of Minnesota, Minneapolis (Not yet recruiting) |
| North Carolina | Duke University, Durham (Not yet recruiting) |
| Texas | The University of Texas MD Anderson Cancer Center, Houston (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.