Study of AZD9829 in CD123+ Hematological Malignancies

Description

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.

Conditions

Hematological Malignancies

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Study Overview

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Study Details

Study overview

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.

A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients With CD123-Positive Hematological Malignancies

Study of AZD9829 in CD123+ Hematological Malignancies

Condition
Hematological Malignancies
Intervention / Treatment

-

Contacts and Locations

Duarte

Research Site, Duarte, California, United States, 91010

Saint Louis

Research Site, Saint Louis, Missouri, United States, 63110

New York

Research Site, New York, New York, United States, 10021

Chapel Hill

Research Site, Chapel Hill, North Carolina, United States, 27514

Columbus

Research Site, Columbus, Ohio, United States, 43210

Houston

Research Site, Houston, Texas, United States, 77030

Milwaukee

Research Site, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥18 years of age;
  • * CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
  • * R/R AML;
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2026-08-04