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Notification report


Full notification file


General information

Notification Number
B/ES/18/13

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
24/05/2018

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?
Yes

If yes, notification number(s):
B/ES/17/05;

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known