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A Phase 1/2, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome

Trial Profile

A Phase 1/2, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Flotetuzumab (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man
  • Sponsors MacroGenics
  • Most Recent Events

    • 19 Oct 2019 Planned number of patients changed from 179 to 197.
    • 17 Jul 2019 According to an MacroGenics media release, at the end of phase 1 the company plans to meet FDA in the third quarter of 2019 to discuss future development of flotetuzumab, and to define a potential registration path for this as monotherapy.
    • 17 Jul 2019 According to an MacroGenics media release, the updated clinical data from this study will be submitted for presentation at the 2019 American Society for Hematology (ASH) Annual Meeting.
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