Long Term Follow-Up of Subjects Exposed to GSK3377794



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:4 - Any
Updated:10/18/2018
Start Date:April 9, 2018
End Date:April 1, 2032
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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

This is a non-therapeutic, multi-center, 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.

This is a non-therapeutic, multi-center, 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.

Inclusion Criteria:

- Subjects who have received at least one dose of GSK3377794 in the interventional
study.

- Subjects who have either completed the interventional study or have withdrawn from it.

- Male or Female subjects.

- Capable of giving signed informed consent prior to the study participation.

Exclusion Criteria:
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Boston, Massachusetts 02115
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Bethesda, Maryland 20892
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Duarte, California 91010
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New York, New York 10032
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Philadelphia, Pennsylvania 19104
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Saint Louis, Missouri 63110
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Tampa, Florida 33612
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