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U 01

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Drug Profile

U 01

Alternative Names: Anti-CD19 chimeric antigen receptor T cell therapy - Shanghai Unicar-Therapy Bio-medicine Technology; Autologous anti-CD19 CAR-T cells expressing a shRNA against IL-6; CD19-CAR-T-Shanghai-Youkadi-Biomedical-Technology; ssCART-19 cell therapy; U-01

Latest Information Update: 04 Jun 2025

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At a glance

  • Originator Shanghai Unicar-Therapy Bio-medicine Technology
  • Developer Shanghai Unicar-Therapy Bio-medicine Technology; Soochow University; The Third Xiangya Hospital of Central South University
  • Class Antineoplastics; CAR-T 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Non-Hodgkin's lymphoma
  • Phase I/II Acute myeloid leukaemia; Diffuse large B cell lymphoma; Leukaemia; Multiple myeloma; Precursor B-cell lymphoblastic leukaemia-lymphoma
  • No development reported Precursor cell lymphoblastic leukaemia-lymphoma

Most Recent Events

  • 22 Apr 2025 Phase-I/II clinical trials in Diffuse large B cell lymphoma (Second-line therapy or greater, In adults, In children, In adolescents) in China (IV) (NCT06987916)
  • 07 Dec 2024 Efficacy and adverse events data from the phase I/II trial in Leukemia presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-2024)
  • 07 Dec 2024 Efficacy and adverse events data from a phase I/II trial in Acute myeloid leukaemia presented at the 66th American Society of Hematology Annual Meeting and Exposition (ASH-2024)

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