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Notification report


Full notification file


General information

Notification Number
B/NL/16/004

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
15/04/2016

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:
01/01/2016 to 31/12/2041

Name of the Institute(s) or Company(ies)
Academic Medical Center, Amsterdam;


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

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known