A Phase I/II, Dose-Escalation study of MGTA-117 in Patients with Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB) ; 117-HEM-101
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.
* To characterize the safety and tolerability of MGTA-117 in R/R AML and MDS-EB patients
* To characterize the PK profile of MGTA-117 in R/R AML and MDS-EB patients
* To characterize the immunogenicity of MGTA-117 in R/R AML and MDS-EB patients
* To establish a minimum safe and biologically effective dose of MGTA-117 in R/R AML and MDS-EB patients
> 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. Identified donor does not need to be medically cleared prior to screening or dosing
Participant's Eastern Cooperative Oncology Group (ECOG) performance status must be > Participant must have adequate baseline hepatic function. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) > 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
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