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 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors

Proposed period of release:
01/12/2019 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?

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

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Genus: Homo; Species: H. sapiens (genetically modified human lymphocytes)
The investigational medicinal product (IMP), ADP-A2M4, are autologous CD4 and CD8 positive T cells that have been transduced with a self-inactivating (SIN) lentiviral vector expressing an enhanced affinity MAGE-A4 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