A Phase I, First-in-Human, Dose Escalation and Expansion Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies

Study Identifier:
CP-MGD024-01
CT.gov Identifier:
NCT05362773
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
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Study Summary

To evaluate MGD024 in patients with CD123+ hematological malignancies.

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Leukemia
  • Myelodysplastic Syndrome
  • Lymphoma
  • Gene Mutations
  • Hematological Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation
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  • Drug: Intervention:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Andrew Sochacki
    Status
    Recruiting
    Condition(s) Treated at Site
    Leukemia
    Myelodysplastic Syndrome
    Lymphoma
    Gene Mutations
    Hematological Cancer