Pre-Screening Test For Clinical Trials Of Autologous Gamma Delta T Lymphocyte Therapy For Advanced Cancer.

e14527 Background: A sub-set of T lymphocytes, the γδ T lymphocytes, play an important role in cancer suppression and modulation of tumour growth, however, the capacity for these cells to proliferate is different between individuals. The authors are developing an autologous γδ T cell therapy, which involves cleanroom-based expansion of γδ T lymphocytes over a two/three week period, which is aimed to be a treatment for a wide-variety of different tumour types. An assay has been created for the identification of the proliferative capacity of γδ T cells as part of a pre-screening test for patients ahead of enrolling into clinical trials with the autologous product. Methods: Patients provide a 10ml blood sample from which peripheral blood mononuclear cells are extracted and used directly in the assay. Cells are expanded over 10 days, during which time they are counted and assessed for viability. Flow cytometry based phenotyping is used to assess the percentage of γδ T cells prior to, and following ex vivo expansion. This permits the calculation of the γδ T cell enrichment factor. This factor is used to determine whether a patient’s cells are capable of meeting the levels of γδ T cell expansion required to provide a single γδ T cell dose (1-10x109cells). Results: Flow cytometry based phenotyping is used to assess the percentage of γδ T cells prior to, and following ex vivo expansion. This permits the calculation of the γδ T cell enrichment factor. This factor is used to determine whether a patient’s cells are capable of meeting the levels of γδ T cell expansion required to provide a single γδ T cell dose (1-10x109cells). Conclusions: Including this pre-screening test in clinical trials with the autologous γδ T lymphocyte therapy will avoid unnecessary procedures for patients being considered for the trials.