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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: 11 Apr 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
  • No development reported Myelodysplastic syndromes
  • Discontinued Lymphoma; Ovarian cancer

Most Recent Events

  • 31 Mar 2025 Marker Therapeutics plans a clinical trial in Acute myeloid leukaemia and Myelodysplastic syndrome in the second half of 2025.
  • 14 Aug 2024 Marker Therapeutics plans a phase I RAPID trial in Acute myeloid leukemia and Myelodysplastic syndrome (In the elderly, Second-line therapy or greater) (IV) in October 2024 (NCT06552416)
  • 25 Mar 2024 The US FDA grants an IND to investigate MT-401 as an “Off-the-Shelf” (MT-401-OTS) product in patients with Acute myeloid leukemia or Myelodysplastic Syndrome before March 2024

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