To assess the emergence, type, severity, and potential causality of delayed adverse events following administration of a gene-modified Treg therapeutic.
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.
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.
Cohort
Prospective
Long Term Safety Monitoring Procedures
Other interventionIn 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.
Incidence of delayed adverse events considered at least possibly related to the SBT777101 gene-modified Treg therapeutic
Persistence of the SBT777101 gene-modified Treg therapeutic
Incidence of replication competent lentivirus (RCL)
Mortality in patients who received a gene-modified Treg therapeutic
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