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

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.

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

Enrolled participants will be determined by the number of subjects participating in the SBT777101-01 and SBT777101-02 studies.