Status:
RECRUITING
Study of AZD9829 in CD123+ Hematological Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 hematologica...
Eligibility Criteria
Inclusion
- ≥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.
Exclusion
- 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 .
Key Trial Info
Start Date :
January 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 7 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06179511
Start Date
January 31 2024
End Date
January 7 2027
Last Update
November 26 2025
Active Locations (24)
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1
Research Site
Duarte, California, United States, 91010
2
Research Site
St Louis, Missouri, United States, 63110
3
Research Site
New York, New York, United States, 10021
4
Research Site
Chapel Hill, North Carolina, United States, 27514