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MGD024

Phase 1

Leukemia, Acute Myeloid | Small molecule | Oncology |MacroGenics, Inc.|Last Updated: May 22, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05362773A Study of MGD024 in Patients With Relapsed or Refractory Hematologic MalignanciesPHASE1 RECRUITING 130 — — Jul 13, 2022May 1, 2027May 22, 20267 United States
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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 — 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)
LOWMay 26, 2026NCT05362773primaryCompletionDate: changed
LOWMay 24, 2026NCT05362773studyFirstPostDate: changed