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
Clinical study CHARIOT – TESSCAR001 titled: A Phase 2 Multi-Center Study Evaluating the Safety and Efficacy of CD30-Directed Genetically Modified Autologous T Cells (CD30.CAR-T) in Adult and Pediatric Patients with Relapsed or Refractory CD30 Positive Classical Hodgkin Lymphoma.

Proposed period of release:
01/03/2020 to 31/05/2021

Name of the Institute(s) or Company(ies)
Tessa Therapeutics Ltd, 8 Temasek Boulevard
#24-02 Suntec Tower 3
038988 Singapore;

3. Is the same GMO release planned elsewhere in the Community?
Italy; Sweden;

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The GMO, referred to as TT11, or CD30-directed genetically modified autologous T cells (CD30.CAR-T) (), consists of human autologous T cells that are genetically modified ex vivo using a recombinant, replication-incompetent retroviral vector (RV), to express a chimeric antigen receptor (CAR) specific for CD30 transmembrane glycoprotein.
Patient T cells are transduced with a retroviral vector encoding the CD30 chimeric antigen receptor (CD30.CAR) and expanded in cell culture, purified, formulated into a suspension, cryopreserved and shipped to the clinical site.

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