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A Phase I/II, Dose-Escalation Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)

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Trial Profile

A Phase I/II, Dose-Escalation Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 14 Feb 2023

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At a glance

  • Drugs MGTA 117 (Primary)
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Magenta Therapeutics

Most Recent Events

  • 06 Feb 2023 Status changed from suspended to discontinued.
  • 25 Jan 2023 Status changed from recruiting to suspended after consultation with the trials safety Cohort Review Committee and with the highest regard for patient safety, as per Magenta Therapeutics media release
  • 25 Jan 2023 According to a Magenta Therapeutics media release, the known information has been reported to the U.S. Food and Drug Administration (FDA) as a Suspected Unexpected Serious Adverse Reaction (SUSAR). After consultation with the trials safety Cohort Review Committee and with the highest regard for patient safety, Magenta has voluntarily paused dosing in the clinical trial and is working to evaluate the totality of available data and determine next steps for the development of MGTA-117

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