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 : Terminated (Sponsor Decision)
First Posted : February 4, 2022
Last Update Posted : February 9, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplasia||Biological: MGTA-117||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||February 2, 2023|
|Actual Study Completion Date :||February 2, 2023|
Experimental: Single dose MGTA-117
Dosing of MGTA-117 prepared and administered by IV infusion.
MGTA-117 will be administered as an IV infusion
- Incidence rate of treatment emergent adverse events (TEAEs) leading to study drug discontinuation [ Time Frame: 21 days ]
- Incidence rate of treatment emergent >= Grade 3 clinical laboratory abnormalities as assessed by CTCAE v5.0 [ Time Frame: 21 days ]
- Assess the clinically significant changes from baseline in vital signs, ECGs and laboratory parameters [ Time Frame: 21 days ]
- Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]Investigate area under the curve (AUC)
- Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]Investigate maximum plasma concentration (Cmax)
- Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]Investigate time of maximum concentration (Tmax)
- Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]Investigate the half-life (t1/2)
- Pharmacokinetics profile of MGTA-117 [ Time Frame: 21 days ]Investigate the plasma concentration
- To establish a minimum safe and biologically effective dose [ Time Frame: 7 days ]Assess the CD117 receptor occupancy in circulating leukemic blasts
- To establish a minimum safe and biologically effective dose [ Time Frame: 21 days ]The incidence of qualifying protocol-defined dose-limiting toxicities
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- The participant has a WHO-defined diagnosis of MDS-EB and has failed/is refractory to HMA
- Presence of MRD in morphologic CR
- 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.
- 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
- 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
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
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Colorado|
|Sarah Cannon Research Institute at HealthONE|
|Denver, Colorado, United States, 80218|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Kansas|
|The University of Kansas Cancer Center|
|Westwood, Kansas, United States, 66205|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Roswell Park Comprehensive Cancer Center|
|Buffalo, New York, United States, 14203|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Responsible Party:||Magenta Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||February 4, 2022 Key Record Dates|
|Last Update Posted:||February 9, 2023|
|Last Verified:||February 2023|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute Myeloid Leukemia
Hematopoietic stem cell transplant
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases