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

Sonoma Biotherapeutics

Status

Enrolling

Conditions

Rheumatoid Arthritis (RA)

Hidradenitis Suppurativa (HS)

Treatments

Other: Long Term Safety Monitoring Procedures

Study type

Observational

Funder types

Industry

Identifiers

NCT07123038

SBT0000-01

Details and patient eligibility

About

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

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 71 years old

Volunteers

No 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