Full notification file
General informationNotification NumberB/ES/18/18Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority06/07/2018Title of the ProjectA phase II trial of tisagenlecleucel in first-line high-risk (HR) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (B-ALL) who are minimal residual disease (MRD) positive at the end of consolidation (EOC) therapyProposed period of release:31/08/2018 to 17/11/2026Name of the Institute(s) or Company(ies)Novartis Pharma AG, Postfach, 4002 Basel, Switzerland;
3. Is the same GMO release planned elsewhere in the Community?Yes: Austria; Belgium; Germany; Denmark; Spain; Finland; France; United Kingdom; Greece; Ireland; Italy; Luxembourg; Netherlands; Portugal; Sweden; Cyprus; Czech Republic; Estonia; Hungary; Lithuania; Latvia; Malta; Poland; Slovenia; Slovak Republic; Iceland; Liechtenstein; Norway; Bulgaria; Romania; Croatia; Has the same GMO been notified elsewhere by the same notifier?YesIf yes, notification number(s): B/DE/15/PEI/2484; B/ES/15/08; B/ES/17/04; B/NL/15/012; GMO characterizationGMO is a:Other: mammalIdentity of the GMO:Autologous T cells transduced with a replication-deficient HIV-1 derived viral vector to express a chimeric (murine/human) antigen receptor (CAR).Information relating to the recipient or parental organisms from wich the GMO is derivedCommon Name | Genus | Species | Subspecies | Strain | Pathovar | human | Homo | Sapiens | - | - | - |
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European Commission administrative informationConsent given by the Member State Competent Authority:Yes13/12/2018 00:00:00Remarks: