Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)

  • STATUS
    Recruiting
  • End date
    Oct 10, 2023
  • participants needed
    55
  • sponsor
    Magenta Therapeutics, Inc.
Updated on 10 May 2022
cancer
myeloid leukemia
myelodysplasia
flow cytometry
leukemia
serum bilirubin level
blast cells
adult acute myelogenous leukemia

Summary

This research study is designed to selectively deplete CD117-positive cells from participants with AML and MDS-EB.

Description

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. The study consists of escalating single-dose cohorts using a standard 3+3 design.

Details
Condition Acute Myeloid Leukemia, Myelodysplasia
Treatment MGTA-117
Clinical Study IdentifierNCT05223699
SponsorMagenta Therapeutics, Inc.
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
Participant's Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2
Participant must have adequate baseline hepatic function. Alanine aminotransferase
(ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤2 x upper
limit of normal (ULN), and serum bilirubin ≤1.5 x ULN
fraction ≥40% or perform New York Heart Association (NYHA) classification I and II
Estimated creatinine clearance ≥60 mL/min
Adequate cardiac function as demonstrated by cardiac left ventricular ejection

Exclusion Criteria

Received HSCT within 6 months prior to dosing
Has active graft-versus-host disease (GVHD)
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
Acute promyelocytic leukemia (APL)
Participant has any clinically significant medical condition, which in the opinion of
Known active central nervous system (CNS) leukemia or chloroma (granulocyte sarcoma)
the Investigator may place the participant at an unacceptable risk
Participant has a history of serious allergic reactions, which in the opinion of the
Active hepatitis B (Hep-B) or hepatitis C (Hep-C) infection or history of human
immunodeficiency virus (HIV)
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
Active uncontrolled systemic bacterial, fungal, or viral infection
Participant has received recent monoclonal antibody as anti-leukemic therapy within
the last 30 days or 5 half-lives, whichever is longer
Investigator may pose an increased risk of serious infusion reactions
Participant has received recent vaccination within the last 14 days prior to dosing
Participant has Grade 2 or higher electrolyte abnormality at screening
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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