Available online 27 September 2022, 104616
Highlights•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.
AbstractBackgroundThis 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.
MethodsThe 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.
ResultsThe 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.
ConclusionsThese preliminary results indicate that the proposed cellular therapy can be considered for further studies in clinical trials.
KeywordsCellular Therapy
Immunotherapy
Cancer
Immune Cells
Autologous Therapy
© 2022 The Author(s). Published by Elsevier Inc.
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