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Notification report


Full notification file


General information

Notification Number
B/DE/16/PEI2572

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
03/11/2015

Title of the Project
A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML) with low blast counts failing to achieve an IWG defined response following azacitidine therapy.

Proposed period of release:
30/04/2015 to 31/12/2017

Name of the Institute(s) or Company(ies)
Cell Therapy Catapult, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; France; United Kingdom;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Identity of the GMO (genus and species)
Genus: Human
Species: Homo Sapiens


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Retroviral vectorMyeloproliferative sarcoma virus----

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
01/06/2016 00:00:00
Remarks: