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 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

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: 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

European Commission administrative information

Consent given by the Member State Competent Authority:
20/02/2018 00:00:00