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Notification report


Full notification file


General information

Notification Number
B/ES/20/19

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/10/2020

Title of the Project
Phase 2 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-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001 cells) in patients with CD19+ acute lymphoid leukemia resistant or refractory to therapy.

Proposed period of release:
01/11/2020 to 30/11/2023

Name of the Institute(s) or Company(ies)
Institut D’Investigacions Biomèdiques Agustí Pi i Sunyer (IDIBAPS), ;


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:
T lymphocytes form patients with acute lymphoblastic leukemia (Homo sapiens sapiens) transduced with the self-inactivating lentiviral vector pCCL to express the chimeric synthetic receptor with anti-CD19 specificity (A3B1), which has been conjugated with 4-1BB as co-stimulatory domain and CD3 as signaling domain (ARI-0001 cells).

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