Long Term Follow-Up of Subjects Exposed to GSK3377794

Official Title

Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor

Summary:

This is a non-therapeutic, multi-centre, long-term follow-up (LTFU) study of subjects who have, during the interventional study, received GSK3377794 generated by a process that utilizes lentiviral vectors. Subjects enrolled in the interventional studies who complete the interventional study or who withdraw from the interventional study will enter this LTFU study and will be followed for up to 15 years from the infusion of genetically modified T lymphocytes. Subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.

Trial Description

Primary Outcome:

• Number of subjects with delayed adverse events (AEs) associated with administration of autologous cells that have been genetically modified by lentiviral vectors

Secondary Outcome:

• Number of subjects with Vesicular Stomatitis Virus G protein (VSV-G) DNA copies
• Number of subjects with Woodchuck hepatitis virus posttranscriptional regulatory element (WPRE) or Psi DNA copies
• Number of subjects with integrated vector sequences and vector integration patterns
• Number of deaths
• Time to death

This is a non-therapeutic, multi-centre, LTFU study of subjects who have, in a previous GlaxoSmithKline (GSK) clinical trial, received GSK3377794 (NY-ESO-1ᶜ²⁵⁹T) by a process that utilizes lentiviral vectors. This protocol is designed in adherence with Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. The study involves up to 15 years post-infusion monitoring of subjects who have been exposed to lentivirus-mediated gene transfer in GSK clinical studies. Subjects will undergo clinical evaluation (i.e., new medical history, physical exam, adverse events, and exposure to mutagenic agents, anti-cancer therapies and investigational products in other clinical studies) with careful attention to adverse events possibly related to gene transfer or lentivirus-induced diseases. Blood samples will be collected for evaluating persistence of cells with lentiviral vector sequences, the detection of replication competent lentivirus (RCL), and chemistry and hematology laboratory assessments. Subjects will be followed for survival.

View this trial on ClinicalTrials.gov