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Notification report


Full notification file


General information

Notification Number
B/ES/17/11

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
16/05/2017

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?
Yes:
Germany; 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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known