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.
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
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