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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI3131

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
05/07/2017

Title of the Project
A Phase I study of MAGE-A1-specific TCR-transduced T cells in patients with relapsed/refractory multiple myeloma

Proposed period of release:
01/09/2016 to 31/01/2020

Name of the Institute(s) or Company(ies)
MAGE-A1 Consortium, Max-Delbrück-Center for Molecular Medicine (MDC), Robert-Rössle-Str. 10, 13125 and Institute of Immunology, Charité Campus Buch, Lindenberger Weg 80, 13125 Berlin
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: Genetically modified autologous T lymphocytes

Identity of the GMO:
Genus: Human
Species: Homo Sapiens
Autologous human CD8+ T cells transduced ex vivo with GMP-grade replication-deficient Myeloproliferative Sarcoma Virus (MPSV)-derived vector (pMP71) containing the gene for a human MAGE-A1-specific T cell receptor (TCR). Expression of the HLA-A*02:01-restricted TCR should enable transduced T cells to recognize and lyse MAGE-A1-expressing (cancer) cells. TCR - and -chain genes are linked by a P2A site to facilitate equimolar expression of both genes. The human constant regions of the TCR - and -chains have each been modified to contain corresponding murine amino acids (4 or 5, respectively) and an additional cysteine residue. The final TCR - and TCR -chain sequences were codon-optimized.


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:
Not known