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 axicabtagene ciloleucel in patients with refractory or relapsed B-cell malignancies. Axicabtagene ciloleucel 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:
01/06/2018 to 31/12/2019

Name of the Institute(s) or Company(ies)
Kite Pharma, Inc., 2225 Colorado Avenue
Santa Monica, CA 90404, USA;

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

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

If yes, notification number(s):
B/DE/17/2858; B/DE/17/PEI2927; B/NL/16/003; B/NL/16/004; B/NL/16/005; B/NL/16/006; B/NL/16/007;

GMO characterization

GMO is a:
Other: mammal

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:
21/06/2018 00:00:00