A study of a vaccine for people with cancer (ACIT-1)

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 1

This study is looking at using a vaccine called allogeneic cell immunotherapy 1 (ACIT-1) vaccine for people with cancer. 

It is open to people with any type of cancer who are going to a cancer clinic at the Royal Liverpool and Broadgreen University Hospital.

More about this trial

ACIT-1 is a cancer vaccine. These vaccines aren’t like vaccines that prevent certain diseases. Cancer vaccines treat people who already have cancer. They do this by working with your own immune system to help it recognise and kill cancer cells. 
 
Your immune system works by seeking out and destroying anything that is harmful to you, such as bacteria and viruses. Or anything that shouldn’t be in your body, such as cancer cells. 
 
But cancer cells make substances (chemicals) that can damp down the immune system. So that it can’t recognise cancer cells and kill them.
 
The ACIT-1 vaccine contains certain types of cells that could help your immune system. 
 
We know from other studies that vaccines like ACIT-1 can work either to stop the cancer growing or reduce the symptoms. 
 
The aims of the study are to find out:
  • how safe the vaccine is
  • what the side effects are
  • how well people cope with having the vaccine
  • if the ACIT-1 vaccine can get your immune system to recognise and kill cancer cells
  • what is the best dose or range of doses to give 

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 
 
You may be able to join this study if all of the following apply:
  • you have cancer 
  • all your other blood results are satisfactory
  • you are up and about, can look after yourself but may not be able to work (performance score 0, 1 or 2)
  • you have a normal heart trace (ECG)
  • you are willing to use reliable contraception during the study and for 3 months afterwards if you or your partner could become pregnant
  • you are at least 18 years old
You cannot join this study if any of these apply. 
 
Cancer related
You:
  • have had cancer treatment in the past 28 days. You might be able to join if you are having standard chemotherapy treatment for cancer of the pancreas or a blood cancer
Medical conditions
You:
  • are taking medication that damps down your immune system in particular steroids with a dose of 10mg or more a day
  • have HIV, hepatitis B, hepatitis C or syphilis
  • have another active infection
  • have taken an experimental drug as part of a clinical trial in past 28 days
  • have had another vaccination in the past 4 weeks 
  • have had antibody treatment in the past 3 months
  • have had major surgery within 2 weeks of being considered for this study
  • are scheduled to have a procedure, such as elective surgery, that means you will have an anaesthetic during the time you are in the study
  • have had a donor cell or organ transplant (an allogeneic transplant)
  • have an active autoimmune disease 
  • have had a serious allergic reaction to any drug
  • have a serious medical condition such as congestive heart failure, angina or an abnormal heartbeat, that isn’t controlled by medication
  • have any other medical or mental health condition that your doctor or study team think could affect you taking part
Other
You are pregnant or breastfeeding.
 

Trial design

This is a phase 1 study. The team need 34 people to join. 
 
You go to the outpatient clinic to have the vaccines. You have the vaccine as an injection into the skin (intradermal injection).
 
There are 4 groups in the study. Each group has a different dose of the vaccine. You have 2 treatments of the vaccine. There are 4 weeks between each treatment.  
 
Depending on which group you are in you might have more than 1 injection at each treatment. You might have the injections in more than 1 limb, your arm and your leg. 
 
After each treatment the nurses in the clinic will monitor you. You might have to stay in the clinic for up to 8 hours to make sure you are okay before going home. 
 
You have a sheet with a list of possible side effects you might have and instructions about how to record them. You also have a phone number to call if you feel unwell at any time. 
 
One or two days after having each treatment a nurse will phone you to see how you are. 
 
Blood samples
During the study a total of 5 blood samples are taken:
  • when you agree to join, to make sure you are able to take part
  • before your 1st treatment
  • before your 2nd treatment
  • 4 weeks after the 2nd treatment
  • 12 weeks later
They will use these samples to find out:
  • how well the vaccines are working
  • to see if the 2nd vaccine treatment has boosted the 1st treatment and helped it to continue to work 
  • more about your cancer and how to treat it

Hospital visits

You see the doctor to have some tests before taking part. These tests include:
  • a physical examination
  • blood tests
  • heart trace (ECG)
  • CT scan 
You see the doctor before each treatment to see how you are.
 
A month after finishing treatment you see the doctor to see how you are. You see them again 12 weeks later when you have a CT scan.
 

Side effects

After injecting the ACIT-1 vaccine just under the skin you will have a small lump. This will gradually go down after a few days. 

The ACIT-1 vaccine is a new treatment and there may be side effects we don’t know about yet. The side effects reported so far are similar to other vaccines used for infectious diseases. 

They are redness, swelling, mild pain or itching where you had the injection. 

On the very rare occasion a small blister might occur. 

You might also have flu like symptoms such as feeling unwell or a high temperature (fever) for a few days after.

Location

Liverpool
Wirral

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Daniel Palmer

Supported by

Cancer Vaccines
Royal Liverpool and Broadgreen University Hospital
Clatterbridge Cancer Centre NHS Foundation Trust
University of Liverpool
Cancer Research UK
National Institute for Health Research (NIHR)
Cancer Vaccines Charitable Trust

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

7743

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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