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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI3970

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
23/12/2019

Title of the Project
Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors

Proposed period of release:
01/04/2020 to 31/12/2023

Name of the Institute(s) or Company(ies)
BioNTech Cell & Gene Therapies GmbH, An der Goldgrube 12, 55131 Mainz, Germany;


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

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 -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
30/06/2020 00:00:00
Remarks: