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
Phase 1 cell dose escalation study to assess the safety and tolerability of genetically engineered MAGE-A10c796T in HLA-A2+ subjects with MAGEA10 positive urothelial, melanoma or head and neck tumors.

Proposed period of release:
05/09/2018 to 15/08/2020

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

3. Is the same GMO release planned elsewhere in the Community?
Not known

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

If yes, notification number(s):

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
The investigational product is defined as MAGE-A10c796T transduced patient-specificautologous T cells that have been transduced with a self-inactivating (SIN) lentiviralvector (LV) encoding a high affinity MAGE-A10 tumour antigen specific T cellreceptor (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:
01/08/2018 00:00:00