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-X19 in patients with refractory or relapsed B cell malignancies

Proposed period of release:
01/03/2019 to 30/06/2021

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; United Kingdom; Italy;

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/DE/17/PEI3037; 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:
Not known