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 (Note: No longer enrolling MDS patients)
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, pharmacodynamics) and to evaluate potential anti-tumor activity of MGD006.
• Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification or MDS with an International Prognostic Scoring System (IPSS) risk category of Intermediate 2 or High Risk
• Patients with AML must be unlikely to benefit from cytotoxic chemotherapy defined by any one of the following criteria:
- leukemia refractory to ≥ 2 induction attempts,
- leukemia in 1st relapse with initial CR duration < 6 months,
- leukemia in 1st relapse following ≥ 1 unsuccessful salvage attempts,
- leukemia in 2nd or higher relapse,
- prior treatment failure with at least two cycles of hypomethylating agent.
• Patients with MDS must have experienced treatment failure with at least one cycle of hypomethylating therapy or induction therapy and have ≥ 10% bone marrow blasts
• Peripheral blast count = 20,000/mm3 at the time of initiation of infusion on Cycle 1 Day 1
John Godwin, M.D.
- Oncology and Hematology Care Eastside