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 pilot study of autologous differentiated T lymphocytes infusion from expanded and transduced peripheral blood to express a chimeric antigen receptor with anti-CD19 specificity in patients with resistant or refractory CD19 + leukemia or lymphoma.

Proposed period of release:
01/04/2017 to 30/06/2018

Name of the Institute(s) or Company(ies)
Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIPAPS), Carrer del Rosselló, 149, 08036 Barcelona;

3. Is the same GMO release planned elsewhere in the Community?

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

GMO characterization

GMO is a:
Other: Mammal

Identity of the GMO:
Homo sapiens and Mus musculus.
Autologous T lymphocytes transduced with a lentivirus to express a chimeric (murine / human) antigenic receptor (CAR) directed against CD19 (ARI-0001 cells).

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:
19/06/2017 00:00:00