Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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

3. Is the same GMO release planned elsewhere in the Community?

Has the same GMO been notified elsewhere by the same notifier?

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known