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
Pilot study of the infusion of differentiated autologous T-cells from
peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity humanized conjugated with the co-stimulatory region 4-
1BB and signal-transduction CD3z (ARI0002h) in patients with relapsed/refractory multiple myeloma with previous treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Proposed period of release:
01/09/2019 to 30/09/2023

Name of the Institute(s) or Company(ies)
Fundació Clinic per a la Recerca Biomèdica, ;

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: mammals

Identity of the GMO:
Identity of the GMO (genus and species): T lymphocytes form multiple myeloma patients (Homo sapiens sapiens) transduced with the self-inactivating lentiviral vector pCCL to express the chimeric synthetic receptor against the BCMA antigen, which has been humanized, with 4-1BB as co-stimulatory domain and CD3 as signaling domain.

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:
04/12/2019 00:00:00