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Brief Title: Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid Leukemia
Official Title: A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM333, a CD33 Targeted Bispecific Antibody Engaging T-cells, in Relapsed or Refractory Acute Myeloid Leukemia
Study ID: NCT03516760
Brief Summary: This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM333 in patients with acute myeloid leukemia (AML). This AML was relapsed after previous therapy or was refractory to the standard therapy.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Universitätsmedizin Mannheim, Mannheim, Baden-Württemberg, Germany
Klinikum rechts der Isar, München, Bayern, Germany
Universitätsklinikum Würzburg, Würzburg, Bayern, Germany
Universitätsklinikum Frankfurt, Frankfurt am Main, Hessen, Germany
Universitätsklinikum Marburg, Marburg, Hessen, Germany
Universitätsklinikum Dresden, Dresden, Sachsen, Germany
Charité Universitätsmedizin, Berlin, , Germany
Name: Martin Wermke, MD
Affiliation: Universitätsklinikum Carl Gustav Carus Dresden
Role: PRINCIPAL_INVESTIGATOR