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Spots Global Cancer Trial Database for Study of MGTA-117 in Patients With Adult Acute Myeloid Leukemia (AML) and Myelodysplasia-Excess Blasts (MDS-EB)

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Trial Identification

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

Interventions

MGTA-117

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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