A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Long Term Safety Monitoring Procedures.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS). Basic parameters: 18 years — 71 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Long Term Safety Monitoring Procedures
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.
Primary outcome measures
- Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic [Time frame: 15 years]
Secondary outcome measures (3)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- UCSF Medical Center — San Francisco
- Stanford Medical Center — Stanford
- University of Colorado — Aurora
- Northwestern University — Chicago
- Tufts University — Boston
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
- University of Minnesota — Minneapolis
- … and 2 more centers
Identifiers
NCT: NCT07123038 · SBT0000-01