Rheumatoid Arthritis (RA)NCT07123038
A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
An observational study of Rheumatoid Arthritis (RA) and Hidradenitis Suppurativa (HS), run by Sonoma Biotherapeutics, Inc. at 10 sites in United States.
Trial summary
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS)
- What is being tested?
- Long Term Safety Monitoring Procedures
- How many people
- 36 participants
- Where
- 10 sitesUnited States
- Study dates
- 22 Jul 2025to Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Enrolled participants will be determined by the number of subjects participating in the SBT777101-01 and SBT777101-02 studies.
Who may be able to join
- 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.
Who cannot join
- Participation in the study is not in the subject's best interest, in the opinion of the Investigator
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Jennifer Seifert, 303-724-7541, jennifer.seifert@cuanschutz.edu
- Recruiting
Tufts University
Boston, Massachusetts, 02111
Andreas Klein, 617-636-5409, tmncccr@tuftsmedicine.org
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Daniella Cook, 617-726-3914, dtcook@mgh.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
James P Sullivan, 617-525-8250, jsullivan126@bwh.harvard.edu
- Recruiting
Northwestern University
Chicago, Illinois, 60611
John Seagrist, 312-503-0565, john.seagrist@northwestern.edu
- Not yet recruiting
Duke University
Durham, North Carolina, 27708
Laura Van Althuis, 919-668-4312, laura.vanalthuis@duke.edu
- Not yet recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Stacie Stutte, 713-794-1918, snstutte@mdanderson.org
- Not yet recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Irmina Wallander, 612-624-5721, wall0396@umn.edu
- Recruiting
UCSF Medical Center
San Francisco, California, 94143
Alex Carvidi, 628-206-2505, alexcarvidi@ucsf.edu
- Recruiting
Stanford Medical Center
Stanford, California, 94305
Uma Vilas Ayachit, 925-860-8966
About this study
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Read the detailed description
The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.
- Being tested
- Long Term Safety Monitoring Procedures
- Keywords
- Rheumatoid Arthritis, Long Term Follow Up Study, Treg, SBT0000-01, Hidradenitis Suppurativa, SBT777101, SBT777101-01, SBT777101-02
- Medical subject headings
- Arthritis, Rheumatoid, Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long Term Safety Monitoring ProceduresOther
In accordance with the schedule of assessments, participants will complete the long term safety and health questionnaire and will undergo routine physical examinations. A review will be conducted on selected adverse events, medical history, and concomitant medication use. Collection of biospecimens (blood and tissue) will be taken as appropriate at scheduled visits to monitor for delayed adverse events related to prior cell therapy.
| Study group | Role | What they receive |
|---|---|---|
| Participants exposed to SBT777101 Treg cell therapy | Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836) Receives: Other: Long Term Safety Monitoring Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
Measured: 15 years
Secondary outcomes (3)
Persistence of the SBT777101 gene-modified Treg therapeutic
Measured: 15 years
Incidence of replication competent lentivirus (RCL)
Measured: 15 years
Mortality in patients who received a gene-modified Treg therapeutic
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start22 Jul 2025
- Primary completionDec 2040 (estimated)
- Study completionDec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonoma Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Baxter, MD, PhD, Study director, Sonoma Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123038
- Sponsor's protocol ID
- SBT0000-01
- Status last verified
- Apr 2026
- First submitted
- 7 Aug 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07123038
- Acronym / sponsor ID
- SBT0000-01
- Keywords
- Rheumatoid Arthritis, Long Term Follow Up Study, Treg, SBT0000-01, Hidradenitis Suppurativa, SBT777101, SBT777101-01, SBT777101-02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sonoma Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Dec 2040 (estimated)
- Study completion
- Dec 2040 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
Detailed description
The purpose of this LTFU study is to evaluate safety (delayed adverse events) for up to 15 years in subjects who have received a gene-modified Treg therapeutic within clinical studies NCT06201416, NCT6361836. This is a Phase 4, multi-center long-term follow-up observational study to evaluate long-term safety in subjects who have received a gene-modified Treg therapeutic across Sonoma Biotherapeutics, Inc. clinical studies. The duration of the study is up to 15 years after dose of a Treg therapeutic in prior parent treatment protocols (SBT777101-01 and SBT777101-02) conducted by the Sponsor. Study visits will occur in accordance with the Schedule of Assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants exposed to SBT777101 Treg cell therapy | – | Other: Long Term Safety Monitoring ProceduresParticipants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836) |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled participants will be determined by the number of subjects participating in the SBT777101-01 and SBT777101-02 studies.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participation in the study is not in the subject's best interest, in the opinion of the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long Term Safety Monitoring ProceduresIn accordance with the schedule of assessments, participants will complete the long term safety and health questionnaire and will undergo routine physical examinations. A review will be conducted on selected adverse events, medical history, and concomitant medication use. Collection of biospecimens (blood and tissue) will be taken as appropriate at scheduled visits to monitor for delayed adverse events related to prior cell therapy. | Other | Participants exposed to SBT777101 Treg cell therapy |
Primary outcome
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
Time frame: 15 years
3 secondary outcomes
Persistence of the SBT777101 gene-modified Treg therapeutic
Time frame: 15 years
Incidence of replication competent lentivirus (RCL)
Time frame: 15 years
Mortality in patients who received a gene-modified Treg therapeutic
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis (RA)
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingPhase 1/2
Efficacy and Safety of Dapagliflozin as an Adjunct to Conventional Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis
Rheumatoid Arthritis (RA
RecruitingPhase 1
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Baxter, MD, PhD study director
Sonoma Biotherapeutics
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA) and Hidradenitis Suppurativa (HS), run by Sonoma Biotherapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Fox-Bosetti, MPH (415-992-6245, clinicaloperations@sonomabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.