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Brief Title: Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)
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)
Study ID: NCT05223699
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 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. The study consists of escalating single-dose cohorts using a standard 3+3 design.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Moffitt Cancer Center, Tampa, Florida, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States