Actively Recruiting
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
Led by MacroGenics · Updated on 2026-05-22
130
Participants Needed
7
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MGD024, a new drug for adults with certain blood cancers that have not responded to standard treatments or have returned after treatment. This Phase 1 trial aims to understand the safety, how the drug acts in the body, immune reactions, and early signs of its effect against these blood cancers. The study is open-label and conducted at multiple centers for patients with select relapsed or refractory hematologic malignancies. Participants will receive MGD024 in cycles lasting 28 days each, for up to 12 cycles or about one year, unless they need to stop earlier. The dose of MGD024 may increase based on safety and tolerability. Response to treatment will be checked after the first cycle and then every two cycles. The drug is designed to target cancer cells expressing CD123 and help the immune system attack them. Throughout the study, participants will be monitored closely for side effects and treatment responses. Assessments include measuring severe side effects during the first 28 days and ongoing tracking of adverse events for up to 12 months. Researchers will also study drug levels in the body, immune reactions, and cancer response rates over time. Participants can expect regular check-ups and tests to evaluate safety and effectiveness during the trial period.
CONDITIONS
Brief Title
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older able to provide informed consent and comply with study procedures
- Diagnosis of relapsed or refractory primary or secondary acute myeloid leukemia (except acute promyelocytic leukemia), myelodysplastic syndrome with prognostic score >3 and <20% bone marrow blasts, classical Hodgkin lymphoma, chronic myelogenous leukemia, B-cell acute lymphocytic leukemia, hairy cell leukemia, advanced systemic mastocytosis, or blastic plasmacytoid dendritic cell neoplasm
- Relapsed after or refractory to at least one prior treatment with no curative option
- At least 20% of malignant cells express CD123
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Life expectancy of at least 12 weeks
- Acceptable laboratory and heart function values
- Mild side effects from prior treatments
- Women and men of childbearing potential agree to use effective contraception during the study and for 4 months after last dose
You will not qualify if you...
- Prior treatment with anti-CD123 agents (except tagraxofusp for BPDCN patients)
- Known central nervous system involvement by the disease
- Conditions or therapies that could interfere with participation or study results
- Systemic anti-cancer, investigational, corticosteroid, or immune-suppressive therapy within 14 days before first dose
- Vaccination with live virus vaccine within 4 weeks before first dose (annual flu and COVID-19 vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive escalating doses of MGD024 to target and eliminate leukemic cells based on safety and tolerability of prior doses.
Visits approximately every 28 to 56 days for dosing and disease response assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here