MERUS (FL & R/R)

A Phase 1, Multinational Study of MCLA-117 in Acute Myelogenous Leukemia

Study treatments

Dose escalation cohorts, with escalating doses of MCLA-117 . The dose is given weekly after initial ramp-up dosing steps. Each Cycle is 28 days. Single agent treatment.

Part 2-Expansion Cohort: MCLA-117 is given weekly after initial ramp-up dosing steps. Each Cycle is 28 days. Single agent treatment.

Inclusion criteria

• Male or female age ≥18 years old
• AML either de novo or secondary [any subtype except acute promyelocytic leukemia (APL)] who either:
  • are in relapse to standard therapy following an initial response
  • failed primary induction therapy with no CR (failed ≥2 induction attempts) and for whom no other approved therapy is available
  • newly diagnosed untreated AML in patients ≥ 65 years of age with high risk cytogenetics, if they are not candidates for standard available induction chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

Exclusion criteria

• Diagnosis of chronic myelogenous leukemia in blast crisis
• Prior hematopoietic stem cell transplantation
• Concurrent need of use of corticosteroids > 10 mg/day of oral prednisone or the equivalent, except topical preparations (e.g., topical creams, steroid inhaler, nasal spray or ophthalmic solution);
• Use of immunosuppressant medications within 4 weeks of MCLA-117 administration;

Participating sites

• ZNA