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MT2021-14 A PHASE I/II, DOSE-ESCALATION STUDY OF MGTA-117 IN PATIENTS WITH ADULT ACUTE MYELOID LEUKEMIA (AML) AND MYELODYSPLASIA-EXCESS BLASTS (MDS-EB)

Recruiting

The overall objective of this study is to investigate the safety, tolerability, PK, PD, and potential anti-leukemia activity of MGTA-117 given intravenously (IV) as a single dose in adults with R/R AML or MDS-EB. Once adequate data are available, the protocol will be amended to assess the safety/tolerability and preliminary efficacy of MGTA-117 in combination with reduced intensity conditioning (RIC) in patients with AML who are proceeding to HSCT.

I'm interested

All
18 Years to 75 Years old
This study is NOT accepting healthy volunteers
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.
• 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 Criteria:

• Acute promyelocytic leukemia (APL).
• Known active central nervous system (CNS) leukemia or chloroma (granulocyte sarcoma).
• Received HSCT 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

Biological: MGTA-117

Acute Myeloid Leukemia, Myelodysplasia

Acute Myeloid Leukemia, Myelodysplasia-Excess Blasts, MGTA-117, Hematopoietic stem cell transplant, Clinics and Surgery Center (CSC)

Helen Fagrelius - fagr0003@umn.edu
Mark Juckett
Phase 1
STUDY00013345
NCT05223699
See this study on ClinicalTrials.gov

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