Kantonsspital St.Gallen

Protocol SAKK 11/16: Personalized and cell-based anti-tumor immunization MVX-ONCO-1 in advanced head and neck squamous cell carcinoma. A single arm, open label, multicenter phase II trial

Markus Joerger

abstract MVX-ONCO-1 is a form of active specific immunotherapy, a process by which the patient’s immune response to tumor cells is stimulated and/or augmented. MVX-ONCO-1 is a patient specific, cell-based, immunotherapy composed of: a. An immune-modulator (GM-CSF: granulocyte-macrophage colony stimulating factor) released from an immuno-protected, encapsulated, allogeneic, genetically modified cell line (MVX-1), and b. Irradiated, autologous tumor cells as source of antigen. The IMP (MVX-ONCO-1) is a medication without marketing authorization in Switzer-land or any other market. MVX-ONCO-1 is an ex-vivo gene therapy (GMO), a transplantation product regulated by the Transplantation Act (Art. 49) in accordance to the Therapeutic Products Act (TPA), the Human Research Act (HRA) and the Clinical Trials Ordinance (ClinO); this trial is classified into clinical trial as a category C.
project partner Dr. Veronika Nagy, Dr. Karen Nestor, Dr. Sabrina Ebinger, Prof. Dr. Markus Joerger, Frau Jessica Hollenstein, Dr. Nikolaus Wagner
type of project clinical studies
status scheduled
start of project 2020
end of project 2025
study design Phase II
responsible person Markus J├Ârge