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

NCT05362773 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CP-MGD024-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 7

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.

Conditions

Classical Hodgkin Lymphoma; Leukemia, Acute Myeloid; Myelodysplastic Syndromes; Leukemia, B-cell; Leukemia, Hairy Cell; Mastocytosis, Aggressive Systemic; Blastic Plasmacytoid Dendritic Cell Neoplasm; Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

• Number of severe side effects in patients receiving MGD024

  Observation of side effects determines the highest safe dose for further study

  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

  Throughout study participation, up to 12 months.

Secondary Outcomes (12)

• Mean maximum concentration

  Throughout study participation, up to 12 months.

• Mean area under the concentration-time curve (AUC)

  Throughout study participation, up to 12 months.

• Number of participants with anti-drug antibody formation

  Throughout study participation, up to 12 months.

• Overall response rate

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

• Complete response rate

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

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.

Drug: MGD024

Interventions

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.

Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MacroGenics: lead

Study Sites (7)

Colorado Blood Cancer Network

Denver, Colorado, 80218, United States

RECRUITING

University of Maryland, Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

START - Midwest

Grand Rapids, Michigan, 49503, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

COMPLETED

South Austin Medical Center

Austin, Texas, 78704, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia, B-Cell; Leukemia, Hairy Cell; Mastocytosis, Systemic; Blastic Plasmacytoid Dendritic Cell Neoplasm; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Mastocytosis; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Mast Cell Activation Disorders; Histiocytic Disorders, Malignant; Lymphoma; Hematologic Neoplasms; Neoplasms by Site; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Denise Casey, M.D.

  MacroGenics

  STUDY DIRECTOR

Central Study Contacts

Global Trial Manager

CONTACT

301-251-5172; info@macrogenics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: July 13, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)