A phase 1 clinical trial published on ClinicalTrials.gov is studying the investigational therapy MGD024 in patients with blood cancers and an inadequate response to standard therapies or a relapse following treatment, including in patients with advanced systemic mastocytosis (SM).
MGD024 is designed to target blood cancer cells expressing CD123, a marker that is overexpressed in some cancer cells.
To participate in the trial, patients must be at least 18 years of age, have blood cancer and have demonstrated an inadequate clinical response to at least one line of treatment. Additionally, patients may not have any treatment options that are potentially curative.
This early-stage study aims to assess side effects to determine the highest dose that remains safe for further study. In addition, this study aims to assess instances of severe adverse events that may necessitate treatment discontinuation. Patients will be checked for side effects throughout the course of the study.
Read more about SM testing and diagnosis
Researchers also want to investigate how the human body reacts to MG024. This includes, for example, the highest concentration of this therapy at the end of infusion, total body exposure following therapy administration, response rates, disease progression (including death) and time frames between relevant clinical points.
The period of study is up to 12 months in length. Patients will be administered MG024 in cycles lasting 28 days each. If patients on MG024 demonstrate a good clinical response, they may continue to be on this therapy after the study has concluded, subject to the discretion of the treating physician.
Advanced SM includes three SM subtypes: aggressive SM, SM with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL). Advanced SM is associated with poor outcomes, with patients commonly experiencing organ damage.
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