Bilateral research project aims to develop immuno-hybrid cell vaccine for the treatment of triple negative breast cancer (TNBC).
Our approach with the preparation and use of autologous immunohybridomas (aHyC), produced by electrofusing monocyte-derived DCs and tumour cells (TCs), is new in the field of TNBC immunotherapy. The same also stands for the concept of concomitant unspecific allogeneic proinflammatory modulation of patients’ immune system aiming at increasing the effectiveness of antitumor activity of immune effector cells.
The study is designed as a phase I / II clinical trial and will be conducted in two parts. In the first part, for the collection of biological samples, all patients with TNRD stages II-III will be included according to the inclusion and exclusion criteria. The second part will include patients with residual tumor after neoadjuvant chemotherapy who will receive experimental treatment with the aHyC vaccine. The primary endpoints of the clinical study are the feasibility and the safety of immune treatment with autologous aHyC cell vaccine after completion of standard treatment of TNBC stage II or III. Secondary endpoints are the evaluation of immune biomarkers, functional properties of effector CTLs, and the extent of T cell proliferation in blood samples from patients before, during, and after receiving aHy and determination of disease-free survival and overall survival of patients receiving aHyC.