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A Phase 1, First-in-Human, Dose Escalation Study of MGD006, a CD123 x CD3 Dual Affinity Re-Targeting (DART) Bi-Specific Antibody-Based Molecule, in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate- 2/High Risk Myelodysplastic Syndrome
The primary goal of this Phase 1, dose-escalation study, is to determine the maximum tolerated dose level of MGD006 in patients with AML and MDS whose disease is not expected to benefit from cytotoxic chemotherapy. Studies will also be done to see how the drug acts in the body (pharmacokinetics [PK], pharmacodynamics) and to evaluate potential anti-tumor activity of MGD006.
The Primary Objective of this study is: To characterize the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose and schedule (MTDS) for the administration of MGD006 when given by continuous intravenous (IV) infusion for seven days in the first week followed by continuous IV infusion either for 4 days on / 3 days off or 7 days continuously during the first of sequential 4-week cycles in patients with relapsed or refractory AML or intermediate-2/high risk MDS. The Secondary Objectives of this study are: - To describe, in preliminary fashion, the safety profile of MGD006 when administered by continuous IV infusion in 4-week cycles over a broad dose range. - To characterize the pharmacokinetics (PK) and immunogenicity of MGD006 when given by continuous IV infusion over a broad dose range. - To describe any evidence of anti-neoplastic activity in AML and MDS. EXPORATORY OBJECTIVES: For patients with MDS, to evaluate the effect of MGD006 on the need for transfusion and/or growth factor support. - To evaluate the utility of CD123 expression on blast cells in AML and MDS as a biomarker. - To evaluate cytokine production by immune effector cells over time. - To evaluate changes in leukemic and normal cells in PBMCs over time. - To evaluate changes in T lymphocyte populations and activation markers over time. - To evaluate changes in leukemic cells, leukemic stem cells and normal progenitor.cells over time in bone marrow. - To evaluate molecular markers of minimal residual disease (MRD). - To examine changes in T lymphocyte repertoire. - To gain experience with the use of certain anti-cytokine agents in the prevention.and/or treatment of life-threatening cytokine release syndrome.