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

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ClinicalTrials.gov Identifier: NCT05223699
Recruitment Status : Recruiting
First Posted : February 4, 2022
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Magenta Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplasia Biological: MGTA-117 Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : February 14, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023


Arm Intervention/treatment
Experimental: Single dose MGTA-117
Dosing of MGTA-117 prepared and administered by IV infusion.
Biological: MGTA-117
MGTA-117 will be administered as an IV infusion




Primary Outcome Measures :
  1. Incidence rate of treatment emergent adverse events (TEAEs) leading to study drug discontinuation [ Time Frame: 21 days ]
  2. Incidence rate of treatment emergent >= Grade 3 clinical laboratory abnormalities as assessed by CTCAE v5.0 [ Time Frame: 21 days ]
  3. Assess the clinically significant changes from baseline in vital signs, ECGs and laboratory parameters [ Time Frame: 21 days ]
  4. Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]
    Investigate area under the curve (AUC)

  5. Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]
    Investigate maximum plasma concentration (Cmax)

  6. Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]
    Investigate time of maximum concentration (Tmax)

  7. Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]
    Investigate the half-life (t1/2)

  8. Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]
    Investigate the plasma concentration

  9. To establish a minimum safe and biologically effective dose [ Time Frame: 7 days ]
    Assess the CD117 receptor occupancy in circulating leukemic blasts

  10. To establish a minimum safe and biologically effective dose [ Time Frame: 21 days ]
    The incidence of qualifying protocol-defined dose-limiting toxicities



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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

  2. CD117+ based on IHC or flow cytometry
  3. Participant must have an identified HSC donor (related donor or unrelated donor), haplo-identical transplant donor, or umbilical blood donor.
  4. Participant's Eastern Cooperative Oncology Group (ECOG) performance status must be ≤2.
  5. 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.
  6. Estimated creatinine clearance ≥60 mL/min
  7. Adequate cardiac function as demonstrated by cardiac left ventricular ejection fraction ≥40% or perform New York Heart Association (NYHA) classification I and II

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05223699


Contacts
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Contact: Magenta Clinical Trials 857-242-0170 Clinicaltrials@magentatx.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Magenta Therapeutics, Inc.
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Responsible Party: Magenta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05223699    
Other Study ID Numbers: 117-HEM-101
First Posted: February 4, 2022    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magenta Therapeutics, Inc.:
Acute Myeloid Leukemia
Myelodysplasia-Excess Blasts
MGTA-117
Hematopoietic stem cell transplant
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions