Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A Phase II, single arm, multicenter open label trial to determine the safety and efficacy of tisagenlecleucel in pediatric patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma (NHL) (BIANCA)

Proposed period of release:
28/01/2019 to 28/01/2023

Name of the Institute(s) or Company(ies)
Novartis Pharma AG, Postfach, 4002 Basel, Switzerland;

3. Is the same GMO release planned elsewhere in the Community?
Austria; Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Ireland; Italy; Luxembourg; Netherlands; Portugal; Sweden; Cyprus; Czech Republic; Estonia; Hungary; Lithuania; Latvia; Malta; Poland; Slovenia; Slovak Republic; Iceland; Liechtenstein; Norway; Bulgaria; Romania; Croatia;

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

If yes, notification number(s):
B/DE/15/PEI/2484; B/ES/15/08; B/ES/17/04; B/ES/18/16; B/ES/18/18; B/NL/15/012;

GMO characterization

GMO is a:
Other: mammals

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known