Investigation of a therapeutic vaccine (ACIT-1) in late stage cancer
Research type
Research Study
Full title
A Phase I clinical study to determine the optimal dose for the safe immune restoration and immune response of allogeneic cell immunotherapy (ACIT-1) in adult cancer patients.
IRAS ID
28730
Contact name
Daniel Palmer
Contact email
Sponsor organisation
Cancer Vaccines Ltd.
Eudract number
2012-005426-30
Research summary
What dose of a cellular cancer vaccine is required to safely raise effective anti-cancer immune responses in patients with pancreatic and other late stage cancers?
Pancreatic cancer has an extremely poor prognosis and is among the top ten cancers in the UK. Treatment options are limited, and even with the current standard treatments patients do not usually live longer than six to twelve months following diagnosis. There is thus an acute need for more effective treatments.
Cancer cells typically secrete chemicals that suppress the immune system so that they escape detection by immune cells, leaving them free to grow. The treatment being tested is a suspension of identical human cells that bear molecules that are commonly found on cancer cells. They are from an unrelated individual which means that the patient’s own immune system will react against them. Research with similar cell therapies indicates that this reaction should help the patient to overcome the immune suppression caused by their cancer. This should then enable them to make specific anti-cancer immune responses against their own cancer cells and it is hoped that this will lead to an improved disease state.
The study will be conducted in a hospital out-patient setting over a period of 20 weeks. Treatment will consist of one or more injections of the cells into the skin on two separate occasions, 4 weeks apart. At various times during the 20 weeks general health checks will be made and blood samples taken to see how a patient’s immune system is responding.
Patients with either pancreatic cancer or other late stage cancers will form parallel arms in the study, each arm containing three patients per dose at four different doses. A further group of ten patients will receive doses to confirm the optimum as determined by blood sample analyses.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
13/NW/0291
Date of REC Opinion
2 Aug 2013
REC opinion
Further Information Favourable Opinion