A Phase I Study of CC-90002 in Patients with Recurrent or Persistent Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Full Title

CC-90002-AML-001: A Phase 1, Open-Label, Dose Finding Study of CC-90002, A Monoclonal Antibody Directed Against CD47, in Subjects with Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome

Purpose

The purpose of this study is to find the highest dose of the investigational drug CC-90002 that can be given safely in patients with high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) that came back or continued to grow despite prior treatment. CC-90002 is an antibody that targets CD47, a protein involved in the growth of AML and MDS. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-risk MDS or persistent or recurrent AML that cannot be cured with standard treatments.
  • At least 4 weeks must pass since the completion of prior anticancer treatment, 3 months since autologous stem cell transplantation, and 6 months since allogeneic stem cell transplantation and entry into the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Martin Tallman at 212-639-3842.

Protocol

17-355

Phase

I

Investigator

Co-Investigators