Kantonsspital St.Gallen
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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

Kurzfassung 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.
   
Projektpartner Dr. Veronika Nagy, Dr. Karen Nestor, Dr. Sabrina Ebinger, Prof. Dr. Markus Joerger, Frau Jessica Hollenstein, Dr. Nikolaus Wagner
Art des Forschungsprojektes Klinische Forschung
Status Geplant
Projektstart 2020
Projektende 2025
Studiendesign Phase II
Verantwortliche Person / Hauptprüfarzt am KSSG Markus Jörge