A trial of Hu5F9-G4 to treat acute myeloid leukaemia and myelodysplastic Syndrome (CAMELLIA)

Cancer type:

Acute leukaemia
Acute myeloid leukaemia (AML)
Blood cancers
Leukaemia

Status:

Open

Phase:

Phase 1

This trial is looking at a new drug called Hu5F9-G4 to treat acute myeloid leukaemia (AML) and myelodysplastic Syndrome (MDS). It is open to people whose AML or MDS has not responded to treatment (refractory) or came back after treatment (relapsed).

More about this trial

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 laboratory studies Open a glossary item 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

  • How well Hu5F9-G4 works for people with AML and MDS
  • How safe it is
  • The best dose of Hu5F9-G4
  • What the side effects are
  • How Hu5F9-G4 works in the body

Who can enter

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

  • Have acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) that has come back after treatment or continued to get worse during treatment and there is no standard treatment Open a glossary item available within 3 weeks of registering for this trial
  • Are willing to have a blood transfusion if necessary
  • Have had your blood group cross matched before starting treatment
  • Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during treatment and for 3 months afterwards if there is any chance you or your partner could become pregnant
  • Are at least 18 years old

You cannot join this trial if any of these apply

  • You have a type of AML called acute promyelocytic leukaemia (APL)
  • Your leukaemia has spread to the brain or spinal cord
  • You have had a donor stem cell transplant (allogeneic stem cell transplant Open a glossary item) in the last 6 months, have active graft versus host disease (GVHD), or you need drugs to suppress your immune system following your transplant 
  • You have already had Hu5F9-G4 or any drug that stops the signals of CD47
  • You have had immunotherapy Open a glossary item, chemotherapy (apart from hydroxycarbamide), or radiotherapy Open a glossary item in the past 4 weeks
  • You have taken an experimental drug as part of another clinical trial in the past 28 days
  • You have a condition that affects the way your blood clots
  • You have certain heart or lung conditions
  • You have HIV, hepatitis B or hepatitis C
  • You have had another cancer in the past 2 years apart from successfully treated non melanoma skin cancer Open a glossary item or successfully treated in situ carcinoma of the cervix that was diagnosed by cone biopsy Open a glossary item
  • You have any other medical or mental health condition that the trial team think could affect you taking part
  • You are pregnant or breastfeeding

Trial design

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 can continue having Hu5F9-G4 for up to a year. 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.

Hospital visits

You see the doctor to have some test before taking part in the trial. These tests include

  • A physical examination
  • Blood tests
  • Eye test
  • Bone marrow test
  • Chest X-ray
  • Heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • Heart trace (ECG Open a glossary item)

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.

Side effects

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

  • High temperature (fever)
  • Chills
  • Headache
  • Rash
  • Itching
  • Change in blood pressure

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.

Location

Cardiff
Leeds
Liverpool
Manchester
Oxford

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 Paresh Vyas

Supported by

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)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

12669

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

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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