GSK3377794 NYESO-1 T-cell therapy alone or with pembrolizumab in NSCLC
Research type
Research Study
Full title
A Phase 1b/2a Pilot Randomized Study to Evaluate the Safety and Tolerability of Autologous T-Cells Expressing Enhanced TCRs (T-Cell Receptors) Specific for NY-ESO-1/LAGE-1a (GSK3377794) Alone, or in Combination with Pembrolizumab in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer
IRAS ID
265216
Contact name
Fiona Thistlethwaite
Contact email
Eudract number
2018-003949-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 29 days
Research summary
GSK3377794 is an experimental therapy being developed for the treatment of non-small cell lung cancer (NSCLC), the most common type of lung cancer. The purpose of the study is to determine if GSK3377794 is effective and with minimal side effects for treating NSCLC. All eligible patients will receive the experimental treatment.
At least 45 patients will be treated with GSK3377794 in this study worldwide, with 2 expected to be from UK Hospitals
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 lung cancer cells, if the cancer has a protein called NY-ESO-1 and/or LAGE-1a.
The study has 4 parts: Screening, Pre-treatment, Treatment, Follow-Up:
Screening: Check patients’ lung cancer cells have the protein NY-ESO-1 and/or LAGE-1a.
Pre-treatment: If a patient is eligible to participate, T-cells will be collected from the patient, sent to a laboratory and modified to become GSK3377794 cells. If required, patients will receive standard cancer treatment while the GSK3377794 cells are made.
Treatment: Before giving GSK3377794, chemotherapy is used to destroy the patient’s existing immune cells. Research indicates this improves the ability of the GSK3377794 T-cells to establish and grow. Some patients will also receive a drug called pembrolizumab every 3 weeks, which may or may not improve the effectiveness of GSK3377794.
Follow-Up: Patients will have follow-up visits (after receiving GSK3377794 T-cells) every 3 weeks for 6 months, then every 3 months until the study ends 2 years after receiving GSK3377794. Patients will be invited to participate in a separate 15-year long-term follow-up study.
Tests undertaken will include but are not limited to: physical exam, vital signs, pregnancy test, imaging scans (CT/MRI), electrocardiogram, blood tests, questionnaires.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0327
Date of REC Opinion
11 Dec 2019
REC opinion
Further Information Favourable Opinion