Status:
TERMINATED
Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)
Lead Sponsor:
Magenta Therapeutics, Inc.
Conditions:
Acute Myeloid Leukemia
Myelodysplasia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This research study is designed to selectively deplete CD117-positive cells from participants with AML and MDS-EB.
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 m...
Eligibility Criteria
Inclusion
- 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
- OR
- \- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05223699
Start Date
February 14 2022
End Date
February 2 2023
Last Update
February 9 2023
Active Locations (8)
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1
City of Hope
Duarte, California, United States, 91010
2
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205