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