Gene-Modified cell therapy: researchers track Long-Term safety in arthritis and skin disease patients
NCT ID NCT07123038
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study monitors 36 people who previously received an experimental gene-modified regulatory T cell (Treg) therapy for rheumatoid arthritis or hidradenitis suppurativa. The goal is to check for any delayed side effects and see how long the modified cells last in the body. Participants are not receiving new treatment, just being observed for safety over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Dec 2040
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Enrolled participants will be determined by the number of subjects participating in the SBT777101-01 and SBT777101-02 studies.
- Ages
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18 to 71 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Duke University
NOT_YET_RECRUITINGDurham, North Carolina, 27708, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Northwestern University
RECRUITINGChicago, Illinois, 60611, United States
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Stanford Medical Center
RECRUITINGStanford, California, 94305, United States
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The University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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Tufts University
RECRUITINGBoston, Massachusetts, 02111, United States
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UCSF Medical Center
RECRUITINGSan Francisco, California, 94143, United States
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University of Colorado
RECRUITINGAurora, Colorado, 80045, United States
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University of Minnesota
NOT_YET_RECRUITINGMinneapolis, Minnesota, 55455, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New pill aims to calm painful skin flares
- Smartphone app aims to catch rheumatoid arthritis before it takes hold
- Can monthly selfies and symptom logs reveal how chronic skin diseases flare and settle?
- Can a Bladder-Derived patch improve wound healing in daily practice?
- A patient questionnaire may rival lab tests for spotting rheumatoid arthritis flares