A phase I trial looking at ACIT-1 immunotherapy for treating people with pancreatic cancer, and other cancers.
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.
Why is this trial being carried out?
In this phase I trial researchers are looking at a new way of treating cancer called immunotherapy. The immune system fights diseases, but it can’t always protect you from cancer. When someone is diagnosed with cancer it means that cancer cells have managed to disguise themselves or hide from the immune system. Immunotherapy works by stimulating the body’s immune system to recognise and attack the cancer cells.
ACIT-1 (allogeneic cell immunotherapy) is a new immunotherapy that has been developed to treat people with cancer. In this trial, researchers want to see if this immunotherapy works for people with:
- pancreatic cancer that is not being treated
- pancreatic cancer that is being treated with the chemotherapy drug gemcitabine
- other types of cancer that have no standard treatment, such as chemotherapy, available.
The ACIT-1 trial will also aim to find out the best and safest dose of ACIT-1.
If you take part in this trial you will have two treatments of ACIT-1. The second treatment will be given four weeks after the first one. At each treatment, you will have between one and six injections, depending on the dose.
You will also have general health checks and blood samples taken, including a CT scan at the start and end of the trial. These tests are to check how well ACIT-1 is working.
If you are due to start gemcitabine chemotherapy, the ACIT-1 treatment will be timed to fit around your chemotherapy, so that you don’t receive both in the same week.
Who is the trial suitable for?
The ACIT-1 trial may be suitable for you if you:
- have pancreatic cancer that can either be treated with gemcitabine, or there is no other treatment available
- have advanced cancer where there is either no treatment available, your treatment has stopped working, or you have decided not to have treatment
- are fit enough to take part in this trial– your trial team will discuss this with you
It may not be suitable for you if you:
- are currently having any medication that can damage your immune system, such as steroids – the trial team will discuss this with you
- have an active infection such as hepatitis, HIV or syphilis – the trial team will discuss this with you
- have had chemotherapy (apart from gemcitabine for pancreatic cancer) or radiotherapy within two weeks of starting the trial
- have had any type of vaccination within four weeks of starting the trial
- have had antibody treatment in the last three months, which is a type of immunotherapy treatment that stimulates your immune system to fight cancer cells
- have either had major surgery within two weeks before starting the trial, or have surgery involving a general anaesthetic planned during the study
- have certain heart problems or other health conditions – the trial team will discuss this with you
- have had another new drug treatment as part of another clinical trial within four weeks of starting this trial.
There may be other reasons for not being able to take part in a trial. It is important to speak to your consultant about whether this trial might be suitable for you.
Recruitment start date: April 2017
Recruitment end date: April 2018
Published December 2017
Review date April 2018
The ACIT-1 trial is being carried out at the Royal University Hospital, Liverpool.
Treatment will take place in the hospital’s Clinical Research Unit. Screening and follow up visits will take place at the Clatterbridge Cancer Centre clinic, which is held in the Linda McCartney Centre (located at the same hospital).
Professor Daniel Palmer
You can contact the trial centre using these contact details:
0151 794 8834 Chloe.Smith@liverpool.ac.uk
0151 794 8167 C.Rawcliffe@liverpool.ac.uk
How to join a trial
Please speak to your consultant about whether this trial is suitable for you. If it is then they can refer you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about the ACIT-1 trial please visit the ClinicalTrials.gov website.
For references used to develop this information please email us.