A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

Description

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, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia

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Study Overview

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Study Details

Study overview

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.

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

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

Condition
Leukemia, Acute Myeloid
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Blood Cancer Network, Denver, Colorado, United States, 80218

Baltimore

University of Maryland, Greenbaum Comprehensive Cancer Center, Baltimore, Maryland, United States, 21201

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Grand Rapids

START - Midwest, Grand Rapids, Michigan, United States, 49503

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27710

Austin

South Austin Medical Center, Austin, Texas, United States, 78704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MacroGenics,

Ashley Ward, M.D., STUDY_DIRECTOR, MacroGenics

Study Record Dates

2025-10