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Notification report


Full notification file


General information

Notification Number
B/ES/19/20

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
30/07/2019

Title of the Project
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Proposed period of release:
01/11/2019 to 31/01/2022

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


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

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The investigational medicinal product (IMP) is defined as ADP-A2M4 transduced patient-specific autologous T cells that have been transduced with a self-inactivating (SIN), replication incompetent lentiviral vector (LV) encoding a high affinity MAGE-A4 tumour antigen specific T cell receptor (TCR).

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanHomosalmonella---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known