Adoptive transfer of activated immune cells against solid tumors: A preliminary study.

• Novel cellular therapy against solid tumors. • Preliminary results of specific cellular therapy administration. • Descriptive and inferential statistical analysis. • Evaluation of efficacy and safety of therapy. This study presents preliminary results concerning the effectiveness of a novel immunotherapy in cancer. The proposed adoptive cellular therapy product contains a mixture of effector immune cells, specifically macrophages, NK cells, dendritic cells, cytotoxic T lymphocytes and monoclonal antibody producing plasma cells. The results were based on both descriptive and inferential statistical analysis of data concerning 17 cancer patients. Particularly, performance scales such as clinical condition, Karnofsky-Index, ECOG index and symptom 's scale were evaluated post therapy administration (4 months). Furthermore, circulating tumor cells (CTCs) and a specific tumor marker (EpCAM) were measured pre- and post-cellular therapy. The results revealed a positive evaluation for clinical condition (70.59 %), Karnofsky-Index (88.23 %), ECOG index (94.12 %), and symptoms' scale (64.70 %). In addition, statistically significant reductions were found for both CTCs (p = 0.0016) and EpCAM positive cells (p = 0.0005), post-therapy, which were related to large size effects, namely 0.77 and 0.85, respectively. No cytokine storm, anaphylaxis or severe adverse events were observed with 4 months follow up evaluation. These preliminary results indicate that the proposed cellular therapy can be considered for further studies in clinical trials. [ABSTRACT FROM AUTHOR]