Long-term safety follow-up after gene-modified regulatory T cell (Treg) therapy
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
Run by Sonoma Biotherapeutics, Inc. · NCT07123038 · Data updated 2026-11-12
This study will see if any delayed side effects occur over 15 years in people who previously got a Sonoma Biotherapeutics gene-modified Treg treatment for conditions like rheumatoid arthritis or hidradenitis suppurativa.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 71 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Sonoma Biotherapeutics, Inc. Industry-sponsored |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Status | Recruiting |
| Started | July 22, 2025 |
| Main results expected | December 2040 |
| Study ends | December 2040 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT07123038 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people who previously received at least one dose of a Sonoma Biotherapeutics gene-modified Treg therapeutic in the sponsor’s parent protocols and who can give informed consent and attend scheduled follow-up visits.
✕Probably not a fit
People who never received the gene-modified Treg therapy, or those judged by the investigator as not suitable to continue follow-up, are unlikely to gain benefit from joining.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational long-term follow-up enrolls people who previously received a Sonoma Biotherapeutics gene-modified Treg therapeutic in specified parent protocols and follows them for up to 15 years to track delayed adverse events. Study visits and safety monitoring procedures occur according to a predefined schedule of assessments, with data collected at UCSF, Stanford, and the University of Colorado. The primary focus is on the emergence, type, severity, and possible causality of delayed adverse events after the original dose. No new investigational treatments are administered as part of this follow-up; it is safety monitoring only.
Why it matters
Potential benefit: If the follow-up finds no concerning delayed effects, it could reassure patients and doctors about the long-term safety of gene-modified Treg therapy and support its wider use.
How similar studies have gone: Early clinical work with regulatory T cell therapies has shown promise in autoimmune conditions, but long-term safety data specifically for gene-modified Tregs remain limited, making this long-term follow-up relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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UCSF Medical Center
San Francisco, California, United States Recruiting -
Stanford Medical Center
Stanford, California, United States Recruiting -
University of Colorado
Aurora, Colorado, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
Tufts University
Boston, Massachusetts, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Show 4 more locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
University of Minnesota
Minneapolis, Minnesota, United States Not yet recruiting -
Duke University
Durham, North Carolina, United States Not yet recruiting -
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Sabrina Fox-Bosetti, MPH
- Email: clinicaloperations@sonomabio.com
- Phone: 415-992-6245
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.