Actively Recruiting
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
Led by MacroGenics · Updated on 2026-01-13
130
Participants Needed
7
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants 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. Participants 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. Participants will be checked for side effects throughout the study.
CONDITIONS
Official Title
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
- Diagnosis of primary or secondary acute myeloid leukemia (except acute promyelocytic leukemia).
- Diagnosis of primary or secondary myelodysplastic syndrome with prognostic score greater than 3 and less than 20% bone marrow blasts.
- Diagnosis of classical Hodgkin lymphoma.
- Diagnosis of chronic myelogenous leukemia.
- Diagnosis of B-cell acute lymphocytic leukemia.
- Diagnosis of hairy cell leukemia.
- Diagnosis of advanced systemic mastocytosis.
- Diagnosis of blastic plasmacytoid dendritic cell neoplasm.
- Relapsed after or refractory to at least one prior line of therapy with no potentially curative treatment option available.
- Evidence of at least 20% of malignant cells expressing CD123.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
- Life expectancy of at least 12 weeks.
- Acceptable laboratory values and heart function.
- Continuing side effects of prior treatment are mild.
- Women and men of childbearing potential agree to use highly effective contraception during the study and for 4 months after the last dose of MGD024.
You will not qualify if you...
- Prior treatment with an anti-CD123-directed agent (except patients with blastic plasmacytoid dendritic cell neoplasm who have received prior tagraxofusp).
- Known involvement of the central nervous system by the disease under study.
- History or current condition, therapy, or lab abnormality that might interfere with trial results or patient participation.
- Use of systemic anti-cancer therapy, investigational therapy, corticosteroids, or other immune suppressive drugs within 14 days before the first dose.
- Vaccination with any live virus vaccine within 4 weeks before the first dose (annual inactivated influenza and SARS-CoV-2 vaccines allowed).
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Colorado Blood Cancer Network
Denver, Colorado, United States, 80218
Actively Recruiting
2
University of Maryland, Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
START - Midwest
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
6
Duke University Medical Center
Durham, North Carolina, United States, 27710
Completed
7
South Austin Medical Center
Austin, Texas, United States, 78704
Actively Recruiting
Research Team
G
Global Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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