Leukemia, Acute MyeloidPhase 1NCT05362773
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study testing MGD024 in people with Leukemia, Acute Myeloid and Myelodysplastic Syndromes, run by MacroGenics at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma
- What is being tested?
- MGD024
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Jul 2022to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 syndrome (MDS) with prognostic score of >3 and <20% bone marrow blasts,
- classical Hodgkin lymphoma (cHL),
- chronic myelogenous leukemia (CML),
Show all 17Show fewer
- b-cell acute lymphocytic leukemia (B-ALL),
- hariy cell leukemia (HCL),
- advanced systemic mastocytosis (ASM), or
- blastic plasmacytoid dendritic cell neoplasm (BPDCM)
- Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
- Evidence of at least 20% of malignant cells with CD123 expression.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- 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 must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.
Who cannot join
- Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
- Known involvement of central nervous system (CNS) by the disease under investigation.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
- Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose
- Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
South Austin Medical Center
Austin, Texas, 78704
University of Maryland, Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Colorado Blood Cancer Network
Denver, Colorado, 80218
Duke University Medical Center
Durham, North Carolina, 27710
START - Midwest
Grand Rapids, Michigan, 49503
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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
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
- Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma, Leukemia, B-cell, Leukemia, Hairy Cell, Mastocytosis, Aggressive Systemic
- Being tested
- MGD024
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Leukemia, B-Cell, Leukemia, Hairy Cell, Mastocytosis, Systemic, Blastic Plasmacytoid Dendritic Cell Neoplasm, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGD024Drug
MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level. Receives: Drug: MGD024 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe side effects in patients receiving MGD024
Observation of side effects determines the highest safe dose for further study
Measured: First 28 days of the study
Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Observation of side effects determines the highest safe dose for further study
Measured: Throughout study participation, up to 12 months.
Secondary outcomes (12)
Mean maximum concentration
The highest concentration of MGD024 at the end of the infusion
Measured: Throughout study participation, up to 12 months.
Mean area under the concentration-time curve (AUC)
Total body exposure to MGD024
Measured: Throughout study participation, up to 12 months.
Number of participants with anti-drug antibody formation
Number of patients who develop antibodies against MDG024
Measured: Throughout study participation, up to 12 months.
Overall response rate
The proportion of patients with a complete response or a partial response to treatment
Measured: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Complete response rate
The proportion of patient achieving a complete response according to disease-specific criteria
Measured: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Median progression free survival
The time between the first dose date to the date of first documented disease-specific progression or death from any cause
Measured: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.Assessed from Day 1 throughout the study until individual participant discontinuation, up to 12 months. Survival from Day 1 throughout the study.
Median time to response
The time between the first dose and the date of complete or partial response.
Measured: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Median duration of response
The time between the date of initial response to the date of disease-specific progression or death from any cause
Measured: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Overall survival
The time between the first dose date to the date of death from any cause
Measured: Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.
Number of participants with AEs and SAEs occurring after administration of tocilizumab or etanercept for cytokine release syndrome (CRS)
Measured: Throughout study participation, up to 12 months.
Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab or etanercept
Measured: Throughout study participation, up to 12 months.
Outcome of CRS event in participants treated with tocilizumab or etanercept
Measured: Throughout study participation, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start13 Jul 2022
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Acute MyeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MacroGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Perabo, MD, PhD, Study director, MacroGenics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362773
- Sponsor's protocol ID
- CP-MGD024-01
- Status last verified
- Jul 2026
- First submitted
- 2 May 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05362773
- Acronym / sponsor ID
- CP-MGD024-01
- Conditions
- Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma, Leukemia, B-cell, Leukemia, Hairy Cell, Mastocytosis, Aggressive Systemic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- MacroGenicsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: MGD024Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
- Participants with
- Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
- Evidence of at least 20% of malignant cells with CD123 expression.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Key exclusion criteria (5 listed)
- Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
- Known involvement of central nervous system (CNS) by the disease under investigation.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
- Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose
- Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGD024MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes. | Drug | Dose Escalation |
Primary outcome
Number of severe side effects in patients receiving MGD024
Time frame: 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.
Time frame: Throughout study participation, up to 12 months.
Observation of side effects determines the highest safe dose for further study
12 secondary outcomes
Mean maximum concentration
Time frame: Throughout study participation, up to 12 months.
Mean area under the concentration-time curve (AUC)
Time frame: Throughout study participation, up to 12 months.
Number of participants with anti-drug antibody formation
Time frame: Throughout study participation, up to 12 months.
Overall response rate
Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Complete response rate
Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Median progression free survival
Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.Assessed from Day 1 throughout the study until individual participant discontinuation, up to 12 months. Survival from Day 1 throughout the study.
Median time to response
Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Median duration of response
Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Overall survival
Time frame: Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.
Number of participants with AEs and SAEs occurring after administration of tocilizumab or etanercept for cytokine release syndrome (CRS)
Time frame: Throughout study participation, up to 12 months.
Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab or etanercept
Time frame: Throughout study participation, up to 12 months.
Outcome of CRS event in participants treated with tocilizumab or etanercept
Time frame: Throughout study participation, up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Perabo, MD, PhD study director
MacroGenics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MGD024 in people with Leukemia, Acute Myeloid and Myelodysplastic Syndromes, run by MacroGenics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of severe side effects in patients receiving MGD024 (time frame: First 28 days of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.