Page contents Full notification Final report General information GMO characterization European Commission administrative Information Return to search

Full notification Final report - General information Notification Number B/CZ/23/04 Member State to which the notification was sent Czech Republic Date of acknowledgement from the Member State Competent Authority 20/07/2023 Title of the Project CARMAN: Early treatment intensification in patients with high risk Mantle Cell Lymphoma using CAR-T-cell treatment after an abbreviated induction therapy with Rituximab and Ibrutinib and 6 months Ibrutinib maintenance (Arm A) as compared to standard of care induction and maintenance (Arm B) Proposed period of release: 01/05/2023 to 30/09/2025 Name of the Institute(s) or Company(ies) LMU Klinikum München, LMU Klinikum München Med. Klinik III Studienzentrale Hämatologie Marchioninistr. 15 81377 München, Germany
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany; Spain; France; Netherlands; Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: Other Identity of the GMO: KTE-X19 consists of autologous human CD3+ T cells transduced ex-vivo with a replication-deficient gamma-retroviral vector (PG13 CD19-H3 Vector) to express a chimeric antigen receptor (CAR) to target CD19 molecules. The GMO is contained in the medicinal product TECARTUS (BREXUCABTAGENE AUTOLEUCEL) which has a marketing authorization in the EU (EU/1/20/1492/001). Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: Homo Species: Homo Sapiens Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Yes
09/27/2023