Full notification file
Member State to which the notification was sent
Date of acknowledgement from the Member State Competent Authority
Title of the Project
A Phase 1/2, Proof-of-Principle, Multi-Center, Open-Label, Single-Arm, Non-randomized Clinical Study to Assess Safety and Efficacy of a Tumor Vaccine Consisting of Genetically Modified Allogeneic (Human) Tumor Cells for the Expression of IL-7, GM-CSF, CD80 and CD154, in Fixed Combination with a DNA-based Double Stem Loop Immunomodulator in Patients with Advanced Renal Cell Carcinoma (ASET Study)
Proposed period of release:
14/12/2010 to 30/06/2015
Name of the Institute(s) or Company(ies)
Mologen AG, Fabeckstr. 30
3. Is the same GMO release planned elsewhere in the Community?
Has the same GMPt been notified elsewhere by the same notifier?
GMO is a:
Identity of the GMO:
Human renal cell carcinoma cells are transduced with human genes coding for GM-CSF, IL-
7, CD80 and CD154 by use of MIDGE vectors. Thereafter, the transduced cells are irradiated. The resulting GMO (MGN1601-W1) is used for the preparation of the cell-based vaccine MGN1601.
Information relating to the recipient or parental organisms from wich the GMO is derived
Caucasian, renal cell carcinoma
European Commission administrative information
Consent given by the Member State Competent Authority: