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Notification report


Full notification file


General information

Notification Number
B/ES/20/14

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
26/10/2020

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?
Yes:
Italy; Sweden;

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known