Evaluation of cNet cells in metastatic or recurrent melanoma
Research type
Research Study
Full title
An open-label, multi-centre, phase I/IIa study evaluating the safety and clinical activity of neoantigen reactive T cells in patients with metastatic or recurrent melanoma.
IRAS ID
254608
Contact name
Samra Turajlic
Contact email
Sponsor organisation
Achilles Therapeutics UK Limited
Eudract number
2018-003446-16
Duration of Study in the UK
3 years, 4 months, 29 days
Research summary
Published literature indicates that tumours arise as a consequence of a series of mutations in normal tissue, and that most tumour growth stems from the original clonal mutations within the tumour. This is a clinical study evaluating the safety and clinical response of a novel personalised therapy (termed ATL001) designed to attack patient specific clonal mutations that are hypothesised to occur solely within all cancer cells.
This clinical study will treat adult patients (aged 18 and over) with metastatic or recurrent melanoma in selected hospitals who have experience handling this type of product and treating this stage of disease. The study will begin with the collection of patient material used to manufacture the therapeutic product. This will involve a surgical procedure and collection of blood samples. Whilst the product is being made patient will undergo standard treatment. Following successful manufacture of the product and as per protocol criteria, patients will be eligible to receive their personalised treatment. This will involve approximately 2 weeks of treatment which includes chemotherapy followed by administration of ATL001, and a product to help ATL001 kill the cancer cells. After this period of treatment, patients will be asked to visit the hospital a number of times over the next 2 year period to give blood samples and to have a scan to see if ATL001 has killed the cancer cells. Each patient will continue to be followed up for a further 5 years, as part of a separate protocol.
If this clinical trial shows that ATL001 is safe and shows a level of effectiveness in treating melanoma, it will likely enable further development of ATL001 for more patients with melanoma and also patients with different cancers all based on the ability to target individual specific clonal mutations within the cancer cells.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0170
Date of REC Opinion
10 May 2019
REC opinion
Further Information Favourable Opinion