A study of CMD 003 T cells for non Hodgkin lymphoma (CITADEL)

Cancer type:

Blood cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2

This study is looking at using CMD 003 T cells to treat a rare type of non Hodgkin lymphoma called NK/T cell lymphoma.

More about this trial

The Epstein Barr virus (EBV) is found in all people who have NK/T cell lymphoma. This virus is able to hide the infected lymphoma cells from the body’s immune system. This means these cells can avoid being found and destroyed.

T cells are a part of the body’s immune system. Researchers want to create T cells that are able to recognise cells infected with the Epstein Barr virus.

To create the T cells you have a blood sample taken. Your blood is then sent to a laboratory and processed to produce the T cells, called CMD 003 T cells. These are then given back to you.

The team hope that, by destroying the EBV-infected cells, the CMD 003 T cells can help shrink the lymphoma.

The aims of this study are to find how well CMD 003 T cells work for NK/T lymphoma and how safe it is. 

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.

There are 2 parts to this study, screening and treatment.

You may be able to join the screening part of this study if you have a rare type of non Hodgkin lymphoma called extranodal NK/T lymphoma and are in one of the following situations.

  • You are unable to have asparaginase chemotherapy
  • Your lymphoma came back or continued to grow for the 1st or 2nd time after having asparaginase
  • Your lymphoma is at a high risk of coming back after your 1st chemotherapy treatment

And all of the following apply:

  • You weigh at least 35kg (5 stone 5 Ilbs)
  • You are well enough to be up for at least half the day (performance status 0, 1 or 2)
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if there is any chance you or your partner could become pregnant
  • You are at least 18 years old

To join the treatment part of this study all of the following must apply.

  • Your lymphoma has come back or continued to get worse after at least 1 treatment of chemotherapy that included asparaginase
  • You have had a scan, blood test or have other signs that show your lymphoma is getting worse
  • You finished your most recent chemotherapy at least 2 weeks before starting treatment
  • You have satisfactory blood test results
  • The level of oxygen in your blood on room air is 90% or more

You cannot join this study if any of these apply.

Cancer related

  • You have lymphoma in the brain or spinal cord
  • Your lymphoma is no longer responding to asparaginase
  • Your lymphoma has come back after treatment 3 times or more
  • You have had a stem cell transplant from a donor (allogeneic transplant Open a glossary item)

Medical conditions

  • You have NK/T cell leukaemia
  • You have HIV, hepatitis B, hepatitis C, HLTV-I or syphilis
  • You are taking steroids within 10 days of taking the blood to make the changed T cells
  • You have had an organ transplant Open a glossary item 
  • You have another cancer apart from non melanoma skin cancer Open a glossary item and in situ carcinoma of the cervix
  • You had another cancer unless it was more than 5 years ago, was treated with the aim to cure and there is no sign of it since and successfully treated non melanoma skin cancer and in situ carcinoma of the cervix
  • A type of white blood cell called lymphocytes Open a glossary item are within the normal limits (for the screening part only)
  • You have an infection that isn’t controlled by drugs
  • You have had a heart attack, heart failure, unstable angina or another serious heart problem in the past 3 months
  • You have any other medical or mental health condition that the study team think could affect you taking part

Other

  • You have already had treatment with your own CMD T cells
  • You are allergic to any of the ingredients of the CMD 003 T cells
  • You are pregnant or breastfeeding

You cannot join the treatment stage of this study if any of the following apply.

  • You have had an experimental drug as part of a clinical trial in the past 4 weeks
  • You have had radiotherapy in the past 3 weeks
  • You have had major surgery in the past 2 weeks
  • You have had signs or symptoms of a severe infection in the past 2 weeks
  • You have steroids the day before starting treatment
  • Your blood test results show that your liver isn’t working well enough

Trial design

This is a phase 2 study. The team need 35 people to treat.

There are 2 parts to this study the screening part and treatment part. You are asked to join each part separately.

Even if you are in the screening part, you might not be able to join the treatment part. Your doctor will talk to you about this and what other treatment is available if this is the case for you.

Screening
You have about 200mls of blood taken. The CMD 003 T cells are made in the laboratory from your blood. This takes about 40 days to do.

During this time your doctor might give you some chemotherapy. They will talk about this with you if needed.

Treatment
You have the CMD 003 T cells as a drip into a vein. This takes about 10 minutes.

You have the 2nd treatment 2 weeks after the first and then at:

  • 2 months
  • 3 months
  • 6 months

You can have up to 5 treatments as long as it is helping and the side effects aren’t too bad.

After each treatment you stay in the clinic for at least 2 hours. So the nurses can monitor you if you have any side effects. You may need to stay longer if the doctor feels it is necessary.

Samples
The researchers will ask for extra blood samples during the study. They use these to see how well the CMD 003 T cells treatment works. And how it affects your immune system Open a glossary item.

If you have a skin wound that is caused by the lymphoma the team will ask for a sample of tissue (biopsy Open a glossary item) of this.

They will also ask people for a biopsy of their lymphoma if a suitable area can be found.

The samples are used to find more about how CMD 003 T cells work and how to improve it. 

Hospital visits

You see the doctor to have some tests before you take part in the treatment part. These include:

  • a physical examination
  • blood tests
  • urine test
  • PET-CT scan

You see the doctor several times for a year for the same tests. During the year you have 4 more PET-CT scans.

After this a member of the study team will phone you 4 times in the next 18 months to see how you.

Side effects

Few side effects have been linked to giving CMD 003 T cells. In some people the T cells have caused inflammation leading to a high temperature (fever), flu like symptoms and swelling where the lymphoma is. Depending on where the lymphoma is this could lead to problems such as breathing difficulties that could be dangerous or life threatening.

This is most likely to happen very soon after having treatment. So you stay in the clinic and are monitored by the staff for at least 2 hours after each treatment. This is to make sure you are okay before sending you home.

Other reactions to having CMD 003 T cells may include:

  • tiredness
  • high temperature (fever)
  • general weakness
  • sore throat
  • skin infections
  • a change to the way the liver works
  • a drop in blood cells causing an increased risk of infection, bruising and bleeding
  • joint pain
  • change in the voice (hoarseness)
  • lumps (nodules) on the legs

Your doctor will talk to you about the side effects of CDM 003 T cells before you agree to take part.

Location

London
Manchester

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 J.A. Radford

Supported by

Cell Medica Ltd
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13886

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think