Spots Global Cancer Trial Database for Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs

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Trial Identification

Brief Title: Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs

Official Title: Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors

Study ID: NCT05292859

Conditions

Gynecologic Cancer

Colorectal Cancer

Pancreatic Cancer

Non-small Cell Lung Cancer

Cholangiocarcinoma

Ovarian Cancer

Ovary Neoplasm

Squamous Cell Lung Cancer

Adenocarcinoma of Lung

Adenosquamous Cell Lung Cancer

Interventions

Neoantigen specific TCR-T cell drug product

Study Description

Brief Summary: Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors

Detailed Description: This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).