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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI3136

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
11/07/2017

Title of the Project
A Phase I/II, Open-Label, Non-Randomized, Multicentre, Dose Escalation Clinical Trial with Control Group to Evaluate the Safety, Feasibility and Preliminary Efficacy of PRAME TCR modified T cells, MDG1011, in Subjects with High Risk Myeloid and Lymphoid Neoplasms

Proposed period of release:
14/12/2017 to 31/12/2022

Name of the Institute(s) or Company(ies)
Medigene AG, Lochhamer Straße 11
D-82152 Planegg/Martinsried
Germany;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Other: Human

Identity of the GMO:
The GMO is used as Investigational Medicinal Product (IMP) and consists of patient-autologous human CD8+ T cells transduced ex vivo with a γ-retroviral self-inactivating (SIN) vector containing the cDNA of the HLA-A*02:01 restricted PRAME-specific T cell receptor (TCR).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
19/12/2017 00:00:00
Remarks: