Long-term safety follow-up after gene-modified regulatory T cell (Treg) therapy
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
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 |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 71 Years |
| Sex | All |
| Sponsor | Sonoma Biotherapeutics, Inc. Industry-sponsored |
| Locations | 10 sites (San Francisco, California and 9 other locations) |
| Trial ID | NCT07123038 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Francisco, California and 9 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.