Long-Term Follow-Up Study to Assess Safety of Gene-Modified Regulatory T Cell Therapy in Adults

What this Trial Is About

This long-term follow-up observational study is designed to assess the safety of a gene-modified regulatory T cell Treg therapeutic in individuals who have previously received this treatment. It focuses on evaluating the type, severity, and possible causes of delayed adverse events over an extended period. The study enrolls adults aged 18 to 71 who have been treated in earlier clinical trials involving the gene-modified Treg therapy. Participants will undergo safety monitoring procedures including completing health questionnaires, routine physical exams, and reviews of medical history and medication use. Biospecimens such as blood and tissue samples will be collected at scheduled visits to detect any delayed adverse events related to the prior cell therapy. The study is planned to last up to 15 years following the initial dose received in parent treatment protocols. Throughout the study, participants will attend visits according to a set schedule for assessments and monitoring. Researchers will measure the incidence of delayed adverse events possibly linked to the gene-modified Treg therapeutic and track persistence of the therapy, replication competent lentivirus incidence, and mortality. The studys long duration allows careful observation of safety outcomes related to the treatment over time.

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