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 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?
France; United Kingdom;

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

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known