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Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.

MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.

MGD024

Global Trial Manager

Eric Winer, MD

Morgan Johnson

Ashley Ward, M.D.

CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in patients with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.

Patients will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Patients will be checked for side effects throughout the study.

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies

Observation of side effects determines the highest safe dose for further study

The highest concentration of MGD024 at the end of the infusion

Number of patients who develop antibodies against MDG024

The proportion of patients with a complete response or a partial response to treatment

The proportion of patient achieving a complete response according to disease-specific criteria

The time between the first dose date to the date of first documented disease-specific progression or death from any cause

The time between the first dose and the date of initial response.

The time between the date of initial response to the date of disease-specific progression or death from any cause

The time between the first dose date to the date of death from any cause

MacroGenics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies	NCT05362773	Leukemia, Acute... Myelodysplastic... Classical Hodgk... Leukemia, B-cel... Leukemia, Hairy... Mastocytosis, A... Blastic Plasmac... Chronic Myeloid...	MGD024	18 Years -	MacroGenics
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies	NCT05362773	Leukemia, Acute... Myelodysplastic... Classical Hodgk... Leukemia, B-cel... Leukemia, Hairy... Mastocytosis, A... Blastic Plasmac... Chronic Myeloid...	MGD024	18 Years -	MacroGenics

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