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Clinical Trial 21352

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT05223699

Phase: Phase I/II
Principal Investigator: Chan, Onyee

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Overview

Study Title

A Phase I/II, Dose-Escalation study of MGTA-117 in Patients with Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB) ; 117-HEM-101

Summary

This is a multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and potential anti-leukemia activity and to establish the minimum safe and biologically-effective dose of a single dose of MGTA-117 in relapsed/refractory (R/R) CD117+ AML participants and participants with MDS-EB.

Objective

Primary: * To characterize the safety and tolerability of MGTA-117 in R/R AML and MDS-EB patients * To characterize the PK profile of MGTA-117 in R/R AML and MDS-EB patients * To characterize the immunogenicity of MGTA-117 in R/R AML and MDS-EB patients * To establish a minimum safe and biologically effective dose of MGTA-117 in R/R AML and MDS-EB patients

Treatments

Therapies

Therapy (NOS)

Medications

MGTA-117 ()

Inclusion Criteria

> Participant must have a World Health Organization (WHO)-defined diagnosis of R/R AML and meet one of the following criteria:

  • The participant has experienced primary AML induction failure or R/R AML OR The participant has a WHO-defined diagnosis of MDS-EB and has failed/is refractory to HMA
  • CD117+ based on IHC or flow cytometry
  • Participant must have an identified HSC donor (related donor or unrelated donor), haplo-identical transplant donor, or umbilical blood donor. Identified donor does not need to be medically cleared prior to screening or dosing
  • Participant's Eastern Cooperative Oncology Group (ECOG) performance status must be > Participant must have adequate baseline hepatic function. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) > Estimated creatinine clearance >60 mL/min
  • Adequate cardiac function as demonstrated by cardiac left ventricular ejection fraction ≥40% or perform New York Heart Association (NYHA) classification I and II
  • Additional criteria may apply

  • Exclusion Criteria

    > Acute promyelocytic leukemia (APL).

  • Known active central nervous system (CNS) leukemia or chloroma (granulocyte sarcoma).
  • Received HSCT within 6 months prior to dosing
  • Received chimeric antigen-receptor cell therapies within 6 months prior to dosing
  • Has active graft-versus-host disease (GVHD).
  • Active hepatitis B (Hep-B) or hepatitis C (Hep-C) infection or history of human immunodeficiency virus (HIV).
  • Participant with a QTc value >470 msec
  • Participant has received another investigational drug or device within 14 days or 5 half-lives of dosing, whichever is longer.
  • Participant has any clinically significant medical condition, which in the opinion of the Investigator may place the participant at an unacceptable risk.
  • Active uncontrolled systemic bacterial, fungal, or viral infection
  • Participant has a history of serious allergic reactions, which in the opinion of the Investigator may pose an increased risk of serious infusion reactions.
  • Participant has had any systemic antileukemia treatment within 14 days except hydroxyurea, which is permitted until 24 hours prior to MGTA-117 dosing.
  • Participant has received prior anti-CD117 antibody treatment.
  • Participant has received gemtuzumab ozogamicin (Mylotarg) within the last 3 months prior to dosing.
  • Participant has received recent monoclonal antibody as anti-leukemic therapy within the last 30 days or 5 half-lives, whichever is longer.
  • Participant has received recent vaccination within the last 14 days prior to dosing.
  • Participant has Grade 2 or higher electrolyte abnormality at screening
  • Additional exclusions may apply

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