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Notification report


Full notification file


General information

Notification Number
B/ES/19/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
28/10/2019

Title of the Project
Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL.

Proposed period of release:
15/01/2020 to 07/12/2022

Name of the Institute(s) or Company(ies)
Novartis Farmacéutica, S.A. Spain, ;


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

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Autologous T cells transduced with a replication-deficient HIV-1 derived viral vector to express a chimeric (murine/human) antigen receptor (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:
Not known