PH1, Long Term Follow-up of Cancer Patients Exposed to NY-ESO-1c259 T
Research type
Research Study
Full title
Long Term Follow-Up of Participants Exposed to GSK3377794 (NY-ESO-1c259 T), a Genetically Engineered NY-ESO-1 Specific T Cell Receptor
IRAS ID
269293
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
Pharm. Research Associates (UK) Ltd.
Eudract number
2018-004888-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
15 years, 3 months, 1 days
Research summary
GSK3377794 is an experimental therapy being developed for the treatment of a number of cancers, such as Non-small cell Lung Cancer and Synovial Sarcoma.
The purpose of this study is to capture Long Term follow-up for patients who have received GSK3377794 in a previous GlaxoSmithKline (GSK) clinical trial.
GSK3377794 is a type of therapy known as T-Cell Receptor-engineered (TCR) T-cell therapy. T-cells are part of the immune system that help kill diseased cells in the body. GSK3377794 T-cell therapy involves modifying the patient’s own T-cells so they can recognise and destroy their cancer cells, if the cancer has a protein called NY-ESO-1 and/or LAGE-1a.
Patients will receive no further experimental treatment during this study.
Patients enrolled in this study will already have participated and received GSK3377794 in prior clinical trials. It is expected that at least 105 patients globally will then participate in this trial with 5 patients expected from UK hospitals.
This study wants to provide long term safety follow-up for all patients who have been exposed to their own genetically modified T-Cells. Patients exposed to gene therapies may be at risk of delayed adverse events (AEs) and this study will continue to follow them for up to 15 years.
After completion/withdrawal of the previous GSK3377794 Trial, the patients will be asked to participate in this study and have follow-up visits at months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60 followed by once yearly visits up to 15 years after their GSK3377794 T-cell infusion.
Tests undertaken will include but are not limited to: recent medical events, physical exam, AEs, blood tests, pregnancy test and quality of life questionnaires.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0006
Date of REC Opinion
12 Mar 2020
REC opinion
Further Information Favourable Opinion