A Phase 1 Study of CSL362 (Anti-IL3Rα / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse

Study Status

Open to Enrollment

Study Description

This is a clinical trial for men and women who have completed chemotherapy for acute myeloid leukemia (AML), have had a complete remission, and are at risk of relapsing (having the disease return).

AML is often not cured because of rare cells called “leukemic stem cells” that are not killed by chemotherapy; only a few of those cells need to survive for the leukemia to grow back. It is thought that these leukemic stem cells need to be completely destroyed before AML can be cured.

This study is evaluating a new experimental treatment called CSL362. CSL362 is an antibody, or protein, that has been designed to attack AML cells. Laboratory testing of CSL362 shows that it specifically targets leukemic stem cells and is able to stop their growth.

The main purpose of this study is to evaluate the safety and tolerability of CSL362 in people who have recently finished their chemotherapy for AML and are in remission. The study will also determine the amount of the study drug in the blood and how long it remains in the body after it is given. Testing will also evaluate how CSL362 affects leukemia cells.

All study participants will receive CSL362, administered via infusion; there is no placebo. Participants will be enrolled into one of five sequential treatment groups testing different doses of CSL362. There is a 16 week treatment period, which includes a final visit 5 weeks after the last dose of CSL362.

Sponsor

CSL Limited

Key Eligibility

  • Men and women age 18 and older
  • CD123+ acute myeloid leukemia (AML)
  • Completed chemotherapy and have had complete remission
  • Considered high risk for relapsed
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Gail Roboz, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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