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Zedenoleucel - Marker Cell Therapy

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Drug Profile

Zedenoleucel - Marker Cell Therapy

Alternative Names: Autologous cytotoxic T-cell therapeutic - Marker Cell Therapeutics; MT-401; MT-401-OTS; MultiTAA T cells Stage; MultiTAA T-cell therapy; MultiTAA-specific T cells; TAA-specific CTLs; Zelenoleucel

Latest Information Update: 24 Nov 2025

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At a glance

  • Originator Marker Therapeutics
  • Developer Baylor College of Medicine; Marker Cell Therapy
  • Class Antineoplastics; Immunotherapies; T lymphocyte cell therapies
  • 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 - Acute myeloid leukaemia
  • New Molecular Entity No

Highest Development Phases

  • Phase II Acute myeloid leukaemia; Breast cancer
  • Phase I/II Multiple myeloma; Precursor cell lymphoblastic leukaemia-lymphoma; Sarcoma
  • Phase I Myelodysplastic syndromes
  • Discontinued Lymphoma; Ovarian cancer

Most Recent Events

  • 30 Oct 2025 Marker Therapeutics terminates the phase II ARTEMIS trial in Acute myeloid leukaemia (Adjuvant therapy, Second-line therapy or greater) in USA (IV, Infusion) due to the long vein-to-vein manufacturing timeline of MT 401 after 38 participants received the autologous MT 401 (NCT04511130)
  • 06 Oct 2025 Preliminary adverse events data from a phase I RAPID trial in Acute myeloid leukaemia and Myelodysplastic syndromes released by Marker Therapeutics
  • 16 Jun 2025 Phase-I clinical trials in Acute myeloid leukaemia (Second-line therapy or greater, In the elderly) in USA (IV) (NCT06552416)

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