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Notification report

Full notification file


General information

Notification Number
B/NL/19/021

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
03/09/2019

Title of the Project
Clinical Trials to Assess the Safety and/or Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells (GSK33777794), alone or in combination with other agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 Participants with NY-ESO-1 and/or LAGE-1a Positive Cancers.

Proposed period of release:
31/08/2019 to 30/09/2049

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


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

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

If yes, notification number(s):
B/ES/17/07; B/ES/19/04;

GMO characterization

GMO is a:
Other:

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 Name	Genus	Species	Subspecies	Strain	Pathovar
Human	Homo	Sapiens	-	-	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/12/2019 00:00:00
Remarks: