Autologous Gamma Delta T Cell Therapy (ImmuniCell®) in Advanced Cancer
Research type
Research Study
Full title
An Adaptive Study of the Safety, Tolerability and Efficacy of Autologous γδ T Lymphocyte Therapy (ImmuniCell®) in Patients with Advanced Cancers which are Refractory to Current Treatment or who have Indolent Disease for which Immunotherapy may be Beneficial
IRAS ID
176768
Contact name
Jeff Evans
Contact email
Sponsor organisation
TC BioPharm Ltd
Eudract number
2015-000402-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 4 months, 14 days
Research summary
Enhancing the immune system can result in a better outcome from treatment of several cancers. One approach is to use the body’s natural immune cells to attack the tumours. A particular type of white blood cell, gamma delta T cell, can recognise and kill many types of cancer cells. This study will investigate if gamma delta T cells can be an effective treatment for cancer. The approach used in this study is to remove some of the patient’s white blood cells by a process called leukapheresis after which the gamma delta T cells are multiplied many times in special conditions. The resultant solution of cells is the treatment being used in this study (ImmuniCell®). The cells are infused back into the same patient to treat their cancer, a process called autologous T cell transfer. Each patient receives one infusion of ImmuniCell® every two weeks over three months. Initially, a small number of patients will be treated to find a safe dose of ImmuniCell® (by increasing the dose each time an infusion is given) until a suitable, safe dose is identified. This dose will be used further to test for an effect in reducing particular cancers: malignant skin cancer, lung cancer and kidney cancer. The patients will spend approximately one year in the study and will be assessed (by CT scan) at regular intervals for the effect of ImmuniCell® on their cancers. Samples will be taken regularly to check for adverse effects on their blood. At the end of this stage of the study, we hope to identify at least one cancer which responds well to treatment and a further stage of the study will be done which involves larger numbers of patients to confirm that ImmuniCell® is effective in that cancer.
REC name
Scotland A REC
REC reference
15/SS/0150
Date of REC Opinion
6 Nov 2015
REC opinion
Further Information Favourable Opinion