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

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 )

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  
• You have another cancer apart from non melanoma skin cancer 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 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