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Notification report


Full notification file


General information

Notification Number
B/ES/19/10

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/06/2019

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?
No

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known