
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Researchers have found that cancer cells have a large amount of a protein called CD47. This protein can stop the body’s immune system removing and destroying cancer cells.
Hu5F9-G4 is a type of biological therapy called a monoclonal antibody. It works by blocking the signals of CD47 that stop the immune system from working.
Researchers know that AML and MDS cells have a large number of CD47. And have shown that Hu5F9-G4 can successfully treat AML. So they think that Hu5F9-G4 may help people with AML and MDS.
Hu5F9-G4 has been used before in the treatment of a small number of patients with AML, but not MDS. It has also been given to a small number of patients with other cancers.
The aims of this trial are to find out
The following bullet points list the entry conditions for this trial. If you are unsure about any of these speak with your doctor or the trial team. They will be able to advise you.
You may be able to join this trial if all of the following apply. You
You cannot join this trial if any of these apply
This is a phase 1 trial. The researchers need up to 40 people to join.
This trial is a dose escalation study. The first few people taking part will have a low dose of Hu5F9-G4. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until they find a dose that is safe and best to give. And that can be used for further clinical trials.
You have Hu5F9-G4 as a drip into a vein. If you have a central line such as a PICC line you have it as an infusion through the line. You have it over 1 to 3 hours, twice a week.
There are 3 parts to this trial. For the 1st part you will receive treatment for 4 weeks.
After 4 weeks if it is still helping and the side effects are not too bad, you can choose to continue having Hu5F9-G4 for a further 8 weeks. This is the 2nd part.
As long as your leukaemia or MDS has not got any worse during these 12 weeks you may be able to stay in the trial and continue having Hu5F9-G4. Your doctor will talk to you about this. This is the 3rd part.
If you choose not to continue your doctor will talk to you about what other treatments are available.
The researchers will take extra blood samples during the trial. They will use these to find out what happens to Hu5F9-G4 in the body.
They will also ask for a sample of your bone marrow to be used for future research in AML and MDS. You don’t have to agree to this if you don’t want to. You can still take part in the trial.
You see the doctor to have some test before taking part in the trial. These tests include
Before starting treatment the researchers will take a photograph of the back of your eye (retina).
You will stay overnight in hospital after your 1st treatment. If your dose increases you will have another overnight stay in hospital.
During treatment you see the doctor regularly for the same tests apart from the heart scan and chest X-ray.
About a month after finishing treatment you see the doctor for the same tests you had at the beginning.
If you still have side effects from taking Hu5F9-G4 you see the doctor every 4 weeks until the side effects are gone. Your doctor will then tell you how often they want to see you.
Hu5F9-G4 is a new drug and there may be side effects we don’t know about yet. You will stay overnight in hospital when you have your first treatment and every time the dose of Hu5F9-G4 is increased. This so you can be monitored closely. And if you are worried about anything you must contact your doctor or the trial team.
You may have a reaction while having Hu5F9-G4 or shortly afterwards. Symptoms of this may include
Hu5F9-G4 may also cause a drop in your red blood cells. You may need to have extra blood transfusions as a result.
Your doctor will talk to you about the possible side effects before you agree to take part in the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Paresh Vyas
Bloodwise
Experimental Cancer Medicine Centre (ECMC)
Forty Seven Inc
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
Stanford University
University of Oxford
California Institute for Regenerative Medicine (CIRM)
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”