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Notification report


Full notification file


General information

Notification Number
B/ES/17/05

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
28/02/2017

Title of the Project
A Phase I, Dose Escalation, Open-Label Clinical Trial Evaluating the Safety and Efficacy of MAGE-A10c796T in Subjects with Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)

Proposed period of release:
01/08/2017 to 31/12/2018

Name of the Institute(s) or Company(ies)
Adaptimmune LLC, ;


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

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: Human T cells

Identity of the GMO:
The investigational product is defined as MAGE-A10c796T transduced patient-specific autologous T cells that have been transduced with a self-inactivating (SIN) lentiviral vector (LV) encoding a high affinity MAGE-A10 tumour antigen 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:
Not known