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 Open Label, Clinical Trial Evaluating the Safety and Anti-tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha-fetoprotein (AFPc332T) in HLA-A2 Positive Subjects with Advanced Hepatocellular Carcinoma (HCC)

Proposed period of release:
01/09/2017 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?
Germany; France; United Kingdom;

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

If yes, notification number(s):

GMO characterization

GMO is a:
Other: Human

Identity of the GMO:
The investigational product is defined as AFPc332T transduced patient-specific autologous T cells that have been transduced with a self-inactivating (SIN) lentiviral vector (LV) encoding a high affinity AFP tumour antigen specific T-cell receptor (TCR).

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:
21/07/2017 00:00:00