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Notification report


Full notification file


General information

Notification Number
B/NL/20/005

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
07/05/2020

Title of the Project
Use of autologous patient-derived T cells enriched from peripheral bloodmononuclear cells (PBMCs) and transduced with a gamma-retroviral self-inactivating(SIN) vector expressing a second generation chimeric antigen receptor (CAR) withspecificity for the oncofetal antigen Claudin6 (CLDN6) under control of an internalpromoter in patients suffering from CLDN6-positive malignancies.

Proposed period of release:
01/04/2020 to 30/03/2040

Name of the Institute(s) or Company(ies)
Erasmus MC, University Medical Center Rotterdam, ;


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

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
Autologous T lymphocytes transduced with replication deficient γ-retroviral self-inactivating vectors expressing chimeric antigen receptor for targeting Claudin-6 (CLDN6).

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
17/07/2020 00:00:00
Remarks: