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Joint Clinical Trials Office

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

Clinical Trial Details

The main purpose of the study is to assess the safety and tolerability of AZD9829 in different dose levels for patients with hematological malignancies.

AZD9829 is considered investigtional, which means it is not approved by the U.S. Food and Drug Administration (FDA). 

All patients will be monitored closely as they would during any other treatment, but special attention will be paid to the monitoring of side effects possibly related to AZD9829. The study will also evaluate how much of the study drug is in the blood at various times, look for immune responses against the study drug, and evaluate how well the cancer is responding to the study drug.
   
AZD9829 will be given as a solution that will be administered intravenously. The dose will be the same for every participant. 
   
Participants will be in this research study for about 1 year. 

Key Eligibility: 

Inclusion Criteria:

  1. Over 18 years of age
  2. CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory; relapsed/refractory (R/R) acute myeloid leukemia (AML); R/R Higher-Risk Myelodysplastic Syndromes (HR-MDS) with greater than 5% bone marrow blast at the time of inclusion
  3. Had at least 1 prior line of therapy at current histology, and have no available treatment options

Exclusion Criteria:

  1. Active central nervous system (CNS) leukemia
  2. Previous treatment with any CD123 targeting therapy
  3. Prior allogeneic HSCT, within 90 or cell therapy within 60 of the start of therapy
  4. Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Pinkal Desai, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2311026748

ClinicalTrials.gov:

NCT06179511

Sponsor:

D9470C00001

Status

Open to Enrollment

Age Group

Adult

Sponsor

  • AstraZeneca

Disease

Hematologic Malignancies
Leukemia
Myelodysplastic Syndrome