OVSTAR TIL trial version 1.0 11 June 2019
Research type
Research Study
Full title
An open label, multi-centre Phase I/IIa study of modified and unmodified autologous Tumour Infiltrating Lymphocytes (TIL) in patients with platinum-resistant ovarian cancer
IRAS ID
255019
Contact name
Fiona Thistlethwaite
Contact email
Sponsor organisation
Immetacyte Ltd (formerly Cellular Therapeutics Ltd)
Eudract number
2019-000106-30
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Ovarian cancer is the sixth most common cancer in women in the UK. The main treatment for advanced disease is surgery followed by platinum-based chemotherapy. In most patients the tumour will then return within 18 months. There is currently no clear standard of care for these patients and there is a need for alternative treatment options.
The purpose of this study is to assess whether we can use patients own immune cells to attack their cancer. Tumour infiltrating lymphocytes (TIL for short) are cells that can get inside tumours and stimulate an immune response to kill tumour (cancer) cells. TIL cells will be taken from a piece of surgically removed tumour and expanded (grown up in large numbers) under carefully controlled conditions in a laboratory. These cells will then be injected back into the patient so that they can attack the cancer. The TIL cells will be given along with chemotherapy and another drug called interleukin 2 (IL-2). TIL therapy is proven to be an efficient treatment for melanoma (a type of skin cancer) and some clinical studies conducted previously have demonstrated that this form of treatment is safe and may be effective in ovarian cancer.
This study will test two different types of TIL treatments:
Unmodified universal autologous TIL (UTIL-01) - TIL cells which have been taken from patients own tumour without any changes being made to them.Modified autologous TIL (CoTIL-01) - TIL cells which have been taken from patients own tumour are modified (altered) with a receptor that may increase their activity making them even better at killing the cancer cells.
The study will initially be run at a single site in the UK and is expected to take 5 years in total and each patient will be in the study for up to 2 years.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0355
Date of REC Opinion
10 Dec 2019
REC opinion
Further Information Favourable Opinion