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Tisagenlecleucel - Novartis/University of Pennsylvania

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Drug Profile

Tisagenlecleucel - Novartis/University of Pennsylvania

Alternative Names: Anti-CD19-CAR retroviral vector-transduced autologous T cells - University of Pennsylvania; Anti-CD19-CAR transduced T cells - Novartis/University of Pennsylvania; Anti-CD19-chimeric-antigen-receptor-peripheral-blood-lymphocytes-Novartis; Anti-CD19-chimeric-antigen-receptor-retroviral-vector-transduced-autologous-T-cells-Novartis; Anti-CD19-chimeric-immune-receptor-retroviral-vector-transduced-autologous-T-cells-Novartis; Anti-CD19-CIR-retroviral-vector-transduced-autologous-T-cell-therapy-Novartis; CART-019; CART-19; CART-19 cells; CART-19-cells-Novartis; CART19-Novartis; CD19-targeted-chimeric-antigen-receptor-immunotherapy-Novartis; Chimeric antigen receptor-modified T cells against CD19 - University of Pennsylvania/Novartis; CTL-019; Kymriah; LG-740; tisagenlecleucel; tisagenlecleucel-T

Latest Information Update: 24 Dec 2019

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At a glance

  • Originator Lentigen Corporation; University of Pennsylvania
  • Developer Beijing Sanwater Biological Technology; Novartis; University of Pennsylvania
  • Class CAR-T cell therapies; Cell therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunologic cytotoxicity; T lymphocyte replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Precursor B-cell lymphoblastic leukaemia-lymphoma; Diffuse large B cell lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Marketed Diffuse large B cell lymphoma; Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Phase III Non-Hodgkin's lymphoma
  • Phase II Follicular lymphoma; Multiple myeloma
  • No development reported B-cell lymphoma; B-cell prolymphocytic leukaemia; Breast cancer; Mantle-cell lymphoma; Mesothelioma; Ovarian cancer; Pancreatic cancer
  • Discontinued Chronic lymphocytic leukaemia

Most Recent Events

  • 16 Jan 2020 Novartis plans a phase II trial for acute lymphoblastic leukemia (Second line therapy or greater; in adolescents, in infants, in children) (NCT04225676)
  • 13 Dec 2019 Oxford BioMedica extends commercial supply agreement with Novartis for the manufacture of lentiviral vectors for the Novartis CAR-T portfolio including five lentiviral vectors for CAR-T products
  • 07 Dec 2019 Pharmacokinetics data from the phase II JULIET trial in Diffuse large B-cell lymphoma presented at the 61st Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2019)
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