RecruitingPhase 1NCT05362773

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

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


Sponsor

MacroGenics

Enrollment

130 participants

Start Date

Jul 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called MGD024 — a bispecific antibody that engages the immune system to fight cancer — in people with relapsed or treatment-resistant blood cancers including leukemia, lymphoma, and related conditions. **You may be eligible if...** - You are 18 or older - You have one of the following cancers that has returned or is not responding to treatment: AML (acute myeloid leukemia), MDS (myelodysplastic syndrome), classical Hodgkin lymphoma, CML (chronic myeloid leukemia), B-cell ALL (acute lymphocytic leukemia), hairy cell leukemia, advanced systemic mastocytosis, or blastic plasmacytoid dendritic cell neoplasm - You are able to provide informed consent and follow study procedures **You may NOT be eligible if...** - You have acute promyelocytic leukemia - You have active brain involvement with your cancer - You have serious heart, liver, or kidney conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMGD024

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


Locations(7)

Colorado Blood Cancer Network

Denver, Colorado, United States

University of Maryland, Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

START - Midwest

Grand Rapids, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

South Austin Medical Center

Austin, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05362773


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