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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07123038

Enrollment

Registered

2025-08-14

Start date

2025-07-22

Completion date

2040-12-01

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa (HS), Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis, Long Term Follow Up Study, Treg, SBT0000-01, Hidradenitis Suppurativa, SBT777101, SBT777101-01, SBT777101-02

Brief summary

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

OTHERLong 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 71 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic	15 years

Secondary

Measure	Time frame
Persistence of the SBT777101 gene-modified Treg therapeutic	15 years
Incidence of replication competent lentivirus (RCL)	15 years
Mortality in patients who received a gene-modified Treg therapeutic	15 years

Countries

United States

Contacts

CONTACTSabrina Fox-Bosetti, MPH

clinicaloperations@sonomabio.com415-992-6245

CONTACTJason Do