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Notification report


Full notification file


General information

Notification Number
B/DE/19/PEI3771

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
06/06/2019

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 CD123 Target Module (TM123) for the Treatment of Patients with Hematologic and Lymphatic Malignancies Positive for CD123

Proposed period of release:
01/10/2019 to 30/06/2022

Name of the Institute(s) or Company(ies)
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?
No

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
MoMuLVGamma retrovirusMoloney murine leukemia virusoncovirinae type C--

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
20/12/2019 00:00:00
Remarks: