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Zamtocabtagene autoleucel - Miltenyi Biomedicine

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Drug Profile

Zamtocabtagene autoleucel - Miltenyi Biomedicine

Alternative Names: Anti-CD20-anti-CD19 CAR T cells - Miltenyi Biotec; Anti-CD2019 CAR T cells; CAR-20/19-T cells - Miltenyi Biotec; CD20-CD19-targeting CAR T Cells - Miltenyi Biotec; CD2019-targeting CAR T cells; DALY II USA; MB-CART2019.1

Latest Information Update: 25 Dec 2025

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At a glance

  • Originator Miltenyi Biotec GmbH
  • 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 III Non-Hodgkin's lymphoma
  • Phase II B-cell lymphoma; Diffuse large B cell lymphoma
  • Phase I/II Multiple sclerosis
  • Clinical Phase Unknown Malignant melanoma; Precursor cell lymphoblastic leukaemia-lymphoma

Most Recent Events

  • 17 Dec 2025 Miltenyi Biotec GmbH plans a phase II DALY II Japan trial for Diffuse-large-B-cell-lymphoma (Second line therapy or greater) in Japan (IV, Infusion) in December 2025 (NCT07288879) (jRCT2033250384)
  • 11 Dec 2025 Efficacy and adverse events data from a phase II DALY 2-EU trial Diffuse large B-cell lymphoma released by Miltenyi Biomedicine
  • 11 Dec 2025 Efficacy data from a phase II DALY 2-USA trial Diffuse large B-cell lymphoma released by Miltenyi Biomedicine

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