Full notification file
General informationNotification NumberB/ES/19/21Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority11/10/2019Title of the ProjectA Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive TumorsProposed period of release:01/12/2019 to 31/01/2022Name of the Institute(s) or Company(ies)Adaptimmune LLC, ;
3. Is the same GMO release planned elsewhere in the Community?Yes: Belgium; Has the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:Other: mammalIdentity of the GMO:Genus: Homo; Species: H. sapiens (genetically modified human lymphocytes)
The investigational medicinal product (IMP), ADP-A2M4, are autologous CD4 and CD8 positive T cells that have been transduced with a self-inactivating (SIN) lentiviral vector expressing an enhanced affinity MAGE-A4 specific T cell receptor (TCR).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:Not known