Long-term Follow-up of Subjects Treated With CAR T Cells

Summary

This is a single site, non-randomized, open-label, long-term safety and efficacy follow-up study for Phase 1 studies that evaluate the safety and efficacy of CAR T cells: NCT05660369 (DF/HCC# 22-175) and NCT06026319 (DF/HCC# 23-474).

Detailed Description

This is a long-term safety and efficacy follow-up study for subjects who have been treated with CAR T cells in corresponding Phase I main studies that evaluated the safety and efficacy of CAR T cells in subjects. No investigational treatment will be administered in this study. The FDA (2020) recommends long-term follow up for subjects treated with gene therapy drug products to monitor for delayed adverse events (AEs), as well as durability of clinical response. Therefore, after monitoring of subjects in the main studies has been completed (24 months after CAR T cells infusion, or \<24 months after CAR T cells infusion if subject terminated early due to disease progression or due to discontinuing corresponding main study for any reason), subjects will be asked to participate in a long-term follow-up study (LTFU). Subjects will be followed for up to 15 years following their last CAR T cells infusion in the corresponding main study.

Eligibility Criteria

Interventions