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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI4042

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
23/03/2020

Title of the Project
Multicenter, open-label, adaptive design phase I trial with genetically modified T-cells carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in combination with PSMA peptide target module (TMpPSMA) for the treatment of patients with progressive disease after standard systemic therapy in cancers with positive PSMA marker

Proposed period of release:
01/07/2020 to 31/12/2022

Name of the Institute(s) or Company(ies)
CPT Cellex Patient Treatment GmbH, Tatzberg 47
01307 Dresden
Germany;


3. Is the same GMO release planned elsewhere in the Community?
No

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

If yes, notification number(s):
B/DE/19/PEI3771;

GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
Genus: Gamma-Retrovirus
Species: Moloney murine leukemia virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Mo-MuLVGamma retrovirusMoloney murine leukemia virusoncovirinae type C--

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
15/10/2020 00:00:00
Remarks: