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Notification report


Full notification file


General information

Notification Number
B/NL/18/009

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
20/06/2018

Title of the Project
Testing the safety and efficacy of KITE-585 (referred to hereafter as KITE-585 or as ‘the genetically modified organism [GMO]’), an autologous cellular immunotherapy composed of a patient’s own T cells engineered to express anti-B-cell maturation antigen (BCMA) chimeric antigen receptors (CARs), in patients with hematologic malignancies in which BCMA is expressed on tumor cells.

Proposed period of release:
01/01/2019 to 01/01/2049

Name of the Institute(s) or Company(ies)
University Medical Center Utrecht, University Medical Center Utrecht;


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

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

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Human T cells transduced with a replication-deficient lentiviral delivery system (293FT-K585 Vector) to express a fully human, anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (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