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NCT05362773 | RECRUITING | Leukemia, Acute Myeloid

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

Macrogenics

Brief 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. 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.

Condition or disease

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

Intervention/treatment

MGD024

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-07-13
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 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.
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

Location Details

NCT05362773

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Colorado Blood Cancer Network

Denver, Colorado, United States, 80218

RECRUITING

United States, Maryland

University of Maryland, Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

RECRUITING

United States, Massachusetts

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

START - Midwest

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

RECRUITING

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

RECRUITING

United States, Texas

South Austin Medical Center

Austin, Texas, United States, 78704