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Inaticabtagene autoleucel - Juventas Cell Therapy/CASI Pharmaceuticals

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Drug Profile

Inaticabtagene autoleucel - Juventas Cell Therapy/CASI Pharmaceuticals

Alternative Names: Anti-CD19 CAR-T cell therapy - Juventas Cell Therapy; CNCT-19; CNTC-19; HI19α-4-1BB-ζ CAR; HY 001; HY-001-Juventas Cell Therapy; HY-001N; Ina-cel

Latest Information Update: 16 Dec 2025

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At a glance

  • Originator Chinese Academy of Medical Sciences
  • Developer CASI Pharmaceuticals; Juventas Cell Therapy
  • 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.

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

Highest Development Phases

  • Registered Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Phase II Non-Hodgkin's lymphoma
  • Phase I/II Diffuse large B cell lymphoma
  • Phase I Autoimmune haemolytic anaemia; Idiopathic thrombocytopenic purpura
  • No development reported B-cell lymphoma

Most Recent Events

  • 10 Dec 2025 Juventas Cell Therapy plans a early phase I trial for Autoimmune diseases of the nervous system (IV) in China in November 2025 (NCT07275736)
  • 04 Dec 2025 Juventas Cell Therapy plans a phase 0 trial for Autoimmune disorders (Treatment-experienced) in unknown location (Parenteral, Injection) in December 2025 (NCT07265206)
  • 27 Jul 2025 Juventas Cell Therapy plans a phase I trial for Autoimmune hemolytic anemia (Treatment-experienced) in July 2025 (NCT07091370)

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