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 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?
Germany; France; Greece; Netherlands;

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

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

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known