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Notification report


Full notification file


General information

Notification Number
B/ES/21/13

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
24/02/2021

Title of the Project
A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects with Advanced Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

Proposed period of release:
01/09/2021 to 31/12/2022

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


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

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
Genus: Homo; Species: H. sapiens (genetically modified human lymphocytes)
The investigational medicinal product (IMP), ADP-A2M4CD8, 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) and an additional wild-type CD8a co-receptor.


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