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
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?

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

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known