Study of AZD9829 in CD123+ Hematological Malignancies

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06179511

Patient View

This Phase I/II study evaluates the safety and efficacy of AZD9829, administered intravenously, in adults with CD123+ hematological malignancies, including R/R AML and R/R HR-MDS with ≥5% bone marrow blasts. Participants must have undergone at least one prior therapy and have an ECOG status of ≤2. The trial explores AZD9829 as monotherapy or in combination.

Patient Parameters

Program 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.

Eligibility Criteria

Inclusion 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.

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria

  • 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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.