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ACIT-1

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.

ACIT-1

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.
Funding Cancer Vaccines Limited
Portfolio Cancer
Interventions Other
Randomised No
Status Recruiting
Start Date 08-Dec-2016

The immune system has an important role in helping prevent cancer by destroying early cancer cells. It does this by seeking out cells with molecular markers called antigens that are tumour-specific. A key player in the cancer cell killing process is the immune T cell. When cancer does develop however, although tumour antigen-specific T cells are present in the blood they are either not responding to the presence of tumour-specific antigens or not effective at killing tumour cells. Vaccines stimulate these T cells to respond and kill cancer cells.
Allogeneic Cell ImmunoTherapy 1 (ACIT-1) is designed to stimulate tumour antigen-specific T cells to respond and kill cancer cells. It contains human cells that bear antigens found on the tumour cells of many kinds of cancer. The same vaccine is therefore applicable for a range of different cancer types. Furthermore, because it consists of cells that are not the patient’s own cells the vaccine stimulates a strong “transplant rejection” immune response helping to boost the anti-cancer immune response. The type of immune response that kills the vaccine cells is the right kind of immune response for killing cancer cells.
ACIT-1 has not been tested in humans before this study therefore the purpose of this study is firstly to check for safety and secondly to find the best dose range for raising effective anti-cancer immune responses. It is also looking at how well immune responses are maintained over time. Four different dose levels are being tested. Treatment comprises one or more intradermal injections of ACIT-1 on two separate occasions approximately one month apart. Immune responses are checked by analysis of blood samples taken at the treatment visits and at follow up visits approximately one month and four months after the second treatment.
Patients are being recruited from two distinct groups. The first group are patients with pancreatic or haematological cancer and these patients receive ACIT-1 treatment alongside standard of care chemotherapy. The second group are patients whose cancer is either of unknown primary origin or has proved to be refractory to other types of treatment. This second group aims to include a range of different cancer types for which no treatment other than ACIT-1 is being received.
The study is listed on the clinicaltrials.gov website at https://clinicaltrials.gov/ct2/show/NCT03096093. It is currently being conducted at the Royal Liverpool Hospital in collaboration with the Royal Liverpool and Broadgreen University Hospitals NHS Trust, Clatterbridge Cancer Centre and the University of Liverpool, and is being sponsored by Cancer Vaccines Ltd, based in Coventry.