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Notification report


Full notification file


General information

Notification Number
B/DE/19/PEI3611

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
19/11/2018

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:
01/04/2019 to 31/12/2035

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?
Yes:
Germany; Spain; United Kingdom; Italy;

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
30/04/2019 00:00:00
Remarks: