A Long-Term Follow-Up Observational Study to Evaluate Safety in Subjects Who Have Received a Gene-Modified Regulatory T Cell (Treg) Therapeutic

Study Purpose

To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 71 Years
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07123038
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sonoma Biotherapeutics, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dr. Mei-Lun Wang, MD
Principal Investigator Affiliation	Sonoma Biotherapeutics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis (RA), Hidradenitis Suppurativa (HS)

Additional Details

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.

Arms & Interventions

Arms

: Participants exposed to SBT777101 Treg cell therapy

Participants exposed to SBT777101 during the original Phase 1 clinical safety study (NCT06201416, NCT06361836)

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Medical Center, San Francisco, California

Status

Recruiting

Address

UCSF Medical Center

San Francisco, California, 94143

Site Contact

Alex Carvidi

[email protected]

628-206-2505

Stanford Medical Center, Stanford, California

Status