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Notification report


Full notification file


General information

Notification Number
B/ES/19/15

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
25/10/2019

Title of the Project
A phase I/IIa clinical trial to assess feasibility, safety and antitumor activity of autologous SLAMF7 CAR-T cells in Multiple myeloma

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

Name of the Institute(s) or Company(ies)
Universitätsklinikum Würzburg, Josef-Schneider Str. 2, 97080 Würzburg, Germany;


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

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
Genus: Homo; Species: H. Sapiens
(genetically modified human lymphocytes)
The GMO are human lymphocytes genetically modified by virus-free Sleeping Beauty
(SB) mediated gene transfer. The modified patient T cells express a SLAMF7-specific
chimeric antigen receptor (CAR) and a truncated version of the human epidermal growth
factor receptor (EGFRt). The CAR consists of an SLAMF7-specific scFv binding domain
(huLuc63) fused to the CD28 and CD3ζ chain signalling domains and recognises the cell
surface marker SLAMF7 which has been identified to be highly and uniformly expressed
on the cell surface of myeloma cells in patients with multiple myeloma (MM).


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
27/01/2020 00:00:00
Remarks: