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Notification report


Full notification file


General information

Notification Number
B/ES/19/19

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
02/08/2019

Title of the Project
Immunotherapy with differentiated, adult, autologous, peripheral blood T lymphocytes, expanded and transduced (genetically modified) using a lentiviral vector to express a chimeric receptor with anti-CD30 specificity associated with costimulatory sequences 4-1-BB and CD3z in patients with Classic Hodgkin lymphoma and non-Hodgkin T lymphoma with CD30 expression.

Proposed period of release:
01/01/2019 to 31/12/2021

Name of the Institute(s) or Company(ies)
Fundació Institut de Recerca de l’Hospital de la
Santa Creu i Sant Pau, C/ Sant Quinti, 77-79. 08041. Barcelona;


3. Is the same GMO release planned elsewhere in the Community?
No

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

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Autologous T lymphocytes transduced with a lentivirus to express a chimeric (murine / human)
antigen receptor (CAR) directed against CD30 (T-CAR30 cells). Homo sapiens.


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