GSK3377794 safety & efficacy in NY-ESO positive solid tumour
Research type
Research Study
Full title
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors
IRAS ID
264778
Contact name
Adam Germaney
Contact email
Eudract number
2019-000415-87
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
GSK3377794 is an experimental therapy being developed for the treatment of synovial sarcoma. Synovial sarcoma is a rare cancer that typically develops around the joints and tendons. The purpose of the study is to determine if GSK3377794 is safe and effective in treating synovial sarcoma. All patients will receive the experimental treatment. The study will take place in two NHS centres and 3 patients are expected to be recruited. 60 patients will participate worldwide.
GSK3377794 is a type of cell therapy known as T-Cell Receptor-engineered (TCR) T-cell therapy. T-cells are cells of the immune system which help to kill diseased cells in the body.
GSK3377794 T-cell therapy involves modifying the patient’s own T-cells so that they can recognise and destroy their synovial sarcoma cells if these have a protein called NY-ESO and/or LAGE.
The study is split into four sections, Screening, Pre-treatment, Treatment and Follow-Up:
Screening: Check patients synovial sarcoma cells have the protein NY-ESO and/or LAGE.
Pre-treatment: If a patient is eligible to participate, T-cells will be collected from the patient. Cells will be sent to a laboratory and will undergo a process to become GSK3377794 cells. If required, patients will receive standard treatment during the time it takes to manufacture the GSK3377794 cells.Treatment: Prior to giving GSK3377794, chemotherapy will be given to destroy the patient’s existing immune cells. Research indicates that this improves the ability of the T-cells to establish and grow.
Follow-Up: patients will have follow-up visits (after the GSK3377794 T-cell infusion) at months 1, 2, 3 to 6, and then every three months, until the end of the study. Then patients will be invited to take part in a 15 years long-term follow-up study.
Tests undertaken will include but are not limited to: physical exam, vital signs, pregnancy test, MRI, CT, electrocardiogram, blood tests, questionnaires.REC name
North East - York Research Ethics Committee
REC reference
19/NE/0321
Date of REC Opinion
11 Dec 2019
REC opinion
Further Information Favourable Opinion