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Advanced post-neoadjuvant treatment of early triple negative breast cancer (TNBC) with autologous cell immunotherapy

BASIC DATA OF THE RESEARCH PROJECT

  • ARRS code: J3-60066

  • TITLE: Advanced post-neoadjuvant treatment of early triple negative breast cancer (TNBC) with autologous cell immunotherapy

  • PRICE CLASS: C
  • PROJECT LEADER: Simona Borštnar, PhD
  • APPLICANT RESEARCH ORGANISATION: Institute of Oncology Ljubljana, University of Ljubljana (Faculty of Pharmacy), CELICA BIOMEDICAL, Blood Transfusion Centre of Slovenia

  • DURATION: 1.1.2025 – 31.12.2027

  • FINANCING: Slovenian Research and Innovation Agency

 

SHORT SUMMARY:

Autologous immunohybridomas (aHyC) are a form of advanced cell therapy and represent a promising new approach for the treatment of triple-negative breast cancer (TNBC), which accounts for approximately 15% of all breast cancers. 

As part of the project, we will conduct a prospective phase I/II clinical study aimed at investigating aHyC-TNBC, prepared from autologous dendritic cells and irradiated tumor cells from the residual tumor. The study will include patients with stage II-III TNBC who have residual tumors following neoadjuvant systemic therapy. 

In the first part of the study (phase I), we will include 6 patients who will receive standard adjuvant therapy (capecitabine and pembrolizumab), followed by metronomic doses of cyclophosphamide and then 3-4 doses of the aHyC-TNBC vaccine. If no serious adverse effects occur, an additional 44 patients will be included in a randomized, open-label phase II clinical study.

 

In phase I, the primary objective will be to assess the safety and tolerability of the aHyC-TNBC vaccine, while in phase II, the primary objective will be the functional evaluation of the cytotoxic activity of CD8+ T lymphocytes and the quantitative assessment of immune cells in peripheral blood samples. Secondary objectives include the evaluation of the safety and feasibility of immunotherapy and the analysis of clinical outcomes, such as disease-free survival and overall survival.