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MGD024

Phase 1

Leukemia, Acute Myeloid | Small molecule | Oncology |MacroGenics, Inc.|Last Updated: Jul 28, 2026

Target and mechanism

Molecular targetCD123
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

MGD024 · 1 trial · 8 indications

Phase 1 1
NCT05362773A Study of MGD024 in Patients With Relapsed or Refractory Hematologic MalignanciesLeukemia, Acute Myeloid
ACTIVE NOT_RECRUITING130 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
Leukemia, Acute MyeloidUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of severe side effects in patients receiving MGD024
First 28 days of the study

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

Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Throughout study participation, up to 12 months.

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

Secondary Endpoints

Mean maximum concentration
Throughout study participation, up to 12 months.
Mean area under the concentration-time curve (AUC)
Throughout study participation, up to 12 months.
Number of participants with anti-drug antibody formation
Throughout study participation, up to 12 months.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
MGD024DRUGMGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures. * Participants with * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia, * primary or secondary myelodysplastic s...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMJul 28, 2026NCT05362773Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJul 28, 2026NCT05362773Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about MGD024

What is MGD024 used for in Acute Myeloid Leukemia?

MGD024 is an investigational therapy being studied for the treatment of relapsed or refractory hematologic malignancies, including acute myeloid leukemia. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in a clinical trial enrolling patients with various blood cancers.

What does MGD024 target?

MGD024 targets CD123, a protein expressed on the surface of certain cells. CD123 is a target of interest in hematologic malignancies because it is found on leukemic cells and other abnormal cells. By targeting CD123, MGD024 aims to direct the immune system against these malignant cells.

Who makes MGD024?

MGD024 is being developed by MacroGenics, Inc., a biopharmaceutical company. MacroGenics is publicly traded on the Nasdaq under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the safety and efficacy of MGD024 in patients with hematologic malignancies.

What phase is MGD024 in?

MGD024 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for commercial use. The Phase 1 trial is designed to assess the safety, tolerability, and preliminary activity of MGD024 in patients with relapsed or refractory hematologic malignancies.

What clinical trials is MGD024 in?

MGD024 is being studied in a Phase 1 clinical trial with the identifier NCT05362773. This trial is titled 'A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies' and is currently active but not recruiting. The trial is enrolling approximately 130 participants in the United States.