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Obecabtagene autoleucel - Autolus

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Drug Profile

Obecabtagene autoleucel - Autolus

Alternative Names: Anti-CD19 CAR T cell therapy - Autolus; AUCATZYL; AUTO 1; CAT19; CD19 CAR T-cells - Autolus; CD19CAT-41BBZ CAR T-cells - Autolus; Obe-cel

Latest Information Update: 09 Oct 2025

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At a glance

  • Originator University College London
  • Developer Autolus; University College London
  • 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 cell lymphoblastic leukaemia-lymphoma
  • New Molecular Entity No

Highest Development Phases

  • Registered Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Phase I/II Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma
  • Phase I Multiple sclerosis; Systemic lupus erythematosus

Most Recent Events

  • 26 Aug 2025 Phase-II clinical trials in Precursor B-cell lymphoblastic leukaemia-lymphoma (First-line therapy) in USA (IV) (NCT07053059)
  • 22 Jul 2025 Phase-I clinical trials in Multiple sclerosis in United Kingdom (IV) (NCT07139743) (EudraCT2024-519552-93-00)
  • 21 Jul 2025 Registered for Precursor B-cell lymphoblastic leukaemia-lymphoma (Second-line therapy or greater) in European Union (IV)

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