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A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

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Trial Profile

A Phase 1/2, Open-label, Multicenter Trial to Assess the Safety and Efficacy of ARD103 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Nov 2024

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At a glance

  • Drugs ARD 103 (Primary) ; Cyclophosphamide (Primary) ; Fludarabine (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors ARCE Therapeutics
  • Most Recent Events

    • 15 Nov 2024 New trial record
    • 18 Oct 2024 According to an Arce therapeutics media release, ARD103 CAR-T has has passed the human investigational new drug review (IND) of the USFDA and has been approved by the U.S. FDA for Phase I/II clinical trials to treat the rare disease acute myeloid leukemia. It is expected to start clinical trials in the Q1 2025 and be included in the acceptance.

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