Study of AZD9829 in CD123+ Hematological Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Hematological Malignancies

In brief

This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.

Key facts

Study ID

NCT06179511

Run by

AstraZeneca

People needed

56

Starts

2024-01-31

Expected to finish

2026-02-24

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age;
• CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
• R/R AML (except APL);
• R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
• Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
• ECOG performance status of ≤ 2.
• The above is a summary, other inclusion criteria details may apply.

You may not qualify if…

• Active CNS leukemia;
• Previous treatment with any CD123 targeting therapy;
• Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
• Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
• History of other malignancy(with certain exceptions);
• Active and uncontrolled infections;
• Unresolved AEs ≥2 Grade, from prior therapies.
• The above is a summary, other exclusion criteria details may apply .

Where it is running

• Research Site — Duarte, California, United States
• Research Site — St Louis, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Chapel Hill, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Houston, Texas, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Heidelberg, Australia
• Research Site — Melbourne, Australia
• Research Site — Tianjin, China
• Research Site — Frankfurt, Germany
• Research Site — Bologna, Italy
• Research Site — Kashiwa, Japan
• Research Site — Osaka, Japan
• Research Site — Yoshida-gun, Japan
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Barcelona, Spain
• Research Site — Salamanca, Spain
• Research Site — Tainan, Taiwan
• Research Site — Taipei, Taiwan
• Research Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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