Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05362773

A Study of MGD024 in Patients With 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Leukemia, Acute Myeloid Blastic Plasmacytoid Dendritic Cell Neoplasm Bone Marrow Diseases Chronic Disease Chronic Myeloid Leukemia Classical Hodgkin Lymphoma Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Histiocytic Disorders, Malignant Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Mast Cell Activation Disorders Mastocytosis Mastocytosis, Aggressive Systemic Mastocytosis, Systemic Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Colorado Blood Cancer Network, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 syndrome (MDS) with prognostic score of >3 and <20% bone marrow blasts,
  • classical Hodgkin lymphoma (cHL),
  • chronic myelogenous leukemia (CML),
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

MGD024

Drug

MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Mean maximum concentration

    Time frame: Throughout study participation, up to 12 months.

    The highest concentration of MGD024 at the end of the infusion

  2. Mean area under the concentration-time curve (AUC)

    Time frame: Throughout study participation, up to 12 months.

    Total body exposure to MGD024

  3. Number of participants with anti-drug antibody formation

    Time frame: Throughout study participation, up to 12 months.

    Number of patients who develop antibodies against MDG024

  4. Overall response rate

    Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.

    The proportion of patients with a complete response or a partial response to treatment

  5. Complete response rate

    Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.

    The proportion of patient achieving a complete response according to disease-specific criteria

  6. 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.

    The time between the first dose date to the date of first documented disease-specific progression or death from any cause

  7. Median time to response

    Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.

    The time between the first dose and the date of complete or partial response.

  8. Median duration of response

    Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.

    The time between the date of initial response to the date of disease-specific progression or death from any cause

  9. Overall survival

    Time frame: Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.

    The time between the first dose date to the date of death from any cause

  10. 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.

  11. 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.

  12. Outcome of CRS event in participants treated with tocilizumab or etanercept

    Time frame: Throughout study participation, up to 12 months.

Sponsors and collaborators

Lead sponsor

MacroGenics

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 5, 2022
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.