PRETZCEL: CD8 Minibody Repeatability Study
Research type
Research Study
Full title
POSITRON EMISSION TOMOGRAPHY REPEATABILITY EVALUATION OF TISSUE ZIRCONIUM 89ZR CREFMIRLIMAB BERDOXAM UPTAKE (PRETZCEL)
IRAS ID
1005934
Contact name
Azeem Saleem
Contact email
Sponsor organisation
ImaginAb, Inc.
Eudract number
2022-000944-31
ISRCTN Number
ISRCTN71215418
Research summary
A type of white blood cells called CD8 T cells are an essential part of the body’s immune defence against cancer and other diseases. However, it is difficult to track these cells in the body. A new agent, crefmirlimab berdoxam, a modified antibody that attaches itself to T cells can be used to track CD8 T cells in the body after it is attached it to a small amount of radioactivity (called as a radiotracer as the radioactivity traces a particular molecule in the body) and imaged with positron emission tomography (PET) scans. For us to use the new agent with confidence in the development of new drugs or for clinical assessment, we need to check if the scanning method is reliable. In this study, we aim to investigate this by doing PET scans twice under similar circumstances in the same patient. Twelve patients, all aged over 18 years old who are either being actively monitored for their kidney cancers or on treatment with immune system modifying therapy (immunotherapy) for their melanoma (a type of skin cancer) will be studied. Scans will be done on each occasion about 24 hours after the injection of the radiotracer. The radiotracer has been well tolerated by more than 100 research participants who have received it, but is yet to be approved for use as a licensed imaging agent. The radiotracer will be manufactured in mainland Europe and transported to UK for study use and given after it is approved for clinical use by the manufacturing site. Each participant will be in the study for up to 12 weeks. Participants will be recruited and scanned at the Hull University Teaching Hospitals NHS Trust and the study expected to be open to recruitment for approximately 12 months.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0137
Date of REC Opinion
2 Sep 2022
REC opinion
Further Information Favourable Opinion