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Notification report

Full notification file


General information

Notification Number
B/ES/19/21

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
11/10/2019

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?
Yes:
Belgium;

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

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 Name	Genus	Species	Subspecies	Strain	Pathovar
Human	Homo	Sapiens	-	-	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known