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
Testing the safety and efficacy of KTE-C19 in patients with refractory or relapsed B cell malignancies. KTE-C19 is a novel adoptive cellular immunotherapy for cancer whereby autologous T cells are genetically modified/transduced ex vivo by a replication-deficient retroviral vector to express anti-CD19 chimeric antigen receptors (CAR) on the surface of T cells to target malignant B cells expressing CD19 antigens.

Proposed period of release:
01/01/2017 to 31/12/2041

Name of the Institute(s) or Company(ies)
University of Tubingen Abteilung I - Universitätsklinik fur Kinder- un-Jungenmedizin, ;
Charité - Universitätsmedizin Berlin, ;
Dr. von Hauner University Children's Hospital Ludwig Maximilians University Munich, ;
Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie;

3. Is the same GMO release planned elsewhere in the Community?
Germany; France; Netherlands;

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

If yes, notification number(s):

GMO characterization

GMO is a:
Other: human T cells

Identity of the GMO:
Human CD3+ T cells transduced with a replication-deficient gamma-retroviral vector (PG13 CD19-H3 Vector) to express a transmembrane CAR.

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:
13/10/2017 00:00:00