This bilateral research project is dedicated to the development of the specific immune-hybrid cellular vaccine for the treatment of triple-negative breast cancer (TNBC). 

The approach, involving preparation and use of autologous immunohybridoma cells (aHyC), engineered with electrofusion of dendritic cells (DC) from autologous monocytes and irradiated tumour cells (TC), represents a novel avenue in the field of immune therapy of TNBC. Additionally, a completely innovative concept involving concurrent non-specific pro-inflammatory modulation of the patients' immune system through allogeneic stimulation, aimed at enhancing the efficacy of  anti-tumour activity of immune effector cells.

The study is designed as a Phase II clinical trial. We will enrol patients with triple-negative stage II-III carcinoma not achieving a complete response with standard neoadjuvant chemotherapy. After obtaining patients’ written informed consent, a portion of the residual tumor will be retrieved post-surgery for aHyC preparation, along with blood samples. Patients with sufficient tumor tissue for aHyC preparation will be randomised into two groups, in a 1:1 ratio: the experimental arm, receiving standard post-neoadjuvant therapy, irradiation and aHyC vaccine, and a control arm, receiving standard therapy, irradiation and placebo.

Primary objectives are: functional evaluation of specific anti-tumour cytotoxic activity of effector cytotoxic T lymphocytes CD8+ (CLT) in vitro, before (baseline) and after experimental treatment with aHyC as well as quantitative evaluation of immune cell populations and subpopulations, namely: natural killer cells (NK cells), T lymphocytes CD8+ and CD4+, B lymphocytes and NKT cells in peripheral blood samples, collected from patients before (baseline), during and after aHyC vaccine administration. Secondary objectives are: to determine safety and feasibility of aHyC vaccine immunotherapy following standard TNBC treatment as well as clinical outcomes (disease-free survival and overall survival).