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Notification report


Full notification file


General information

Notification Number
B/DE/18/PEI3320

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
22/01/2018

Title of the Project
Testing the safety and efficacy of axicabtagene ciloleucel in patients with refractory or relapsed B cell malignancies. Axicabtagene ciloleucel is a novel adoptive cellular immunotherapy for cancer whereby autologous T cells are genetically modified/transduced ex vivo by a replication-deficient retroviral vector to express anti-CD19 chimeric antigen receptors (CAR) on the surface of T cells to target malignant B cells expressing CD19 antigens.

Proposed period of release:
01/04/2017 to 31/12/2041

Name of the Institute(s) or Company(ies)
Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik I.;
Universitätklinikum Münster, Gebaeude 1, Albert-Schweizer-Campus 1;
Universitätklinikum Heidelberg, Medizinische Klinik V;


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

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

If yes, notification number(s):
B/DE/17/2858; B/DE/17/PEI2927; B/NL/16/003; B/NL/16/004; B/NL/16/005; B/NL/16/006; B/NL/16/007;

GMO characterization

GMO is a:
Other: Mammal

Identity of the GMO:
Human CD3+ T cells transduced with a replication-deficient gamma-retroviral vector (PG13 CD19-H3 Vector) to express a transmembrane CAR.

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
06/08/2018 00:00:00
Remarks: