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Notification report


Full notification file


General information

Notification Number
B/ES/19/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/12/2018

Title of the Project
A Phase 1b/2a Pilot Randomized Study to Evaluate the Safety and Tolerability of Autologous T Cells Expressing Enhanced TCRs (T Cell Receptors) Specific for NY ESO 1/LAGE-1a (GSK3377794) Alone, or in Combination with Anti-PD1 Therapy in HLA-A2+ Participants with NY-ESO-1- or LAGE-1a-Positive Advanced or Recurrent Non-Small Cell Lung Cancer

Proposed period of release:
01/06/2019 to 30/04/2021

Name of the Institute(s) or Company(ies)
GlaxoSmithKline R&D, ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Netherlands;

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

If yes, notification number(s):
B/ES/17/07;

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
The investigational product, also called GSK3377794, is comprised of autologous T cells that have been transduced with GSK3988862A, a self-inactivating lentiviral vector encoding a T cell receptor (TCR) targeted to recognize NY-ESO-1/LAGE1.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
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European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
25/06/2019 00:00:00
Remarks: