RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-07-13
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05362773

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
  2. * Participants with
  3. * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,
  4. * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \>3 and \<20% bone marrow blasts,
  5. * classical Hodgkin lymphoma (cHL),
  6. * chronic myelogenous leukemia (CML),
  7. * b-cell acute lymphocytic leukemia (B-ALL),
  8. * hariy cell leukemia (HCL),
  9. * advanced systemic mastocytosis (ASM), or
  10. * blastic plasmacytoid dendritic cell neoplasm (BPDCM)
  11. * Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
  12. * Evidence of CD123 expression
  13. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
  14. * Life expectancy of at least 12 weeks.
  15. * Acceptable laboratory values, and heart function.
  16. * Continuing side effects of prior treatment are mild
  17. * 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.
  1. * Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
  2. * Known involvement of central nervous system (CNS) by the disease under investigation.
  3. * 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.
  4. * Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose
  5. * Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.

Contacts and Locations

Study Contact

Global Trial Manager
CONTACT
301-251-5172
info@macrogenics.com

Principal Investigator

Ashley Ward, M.D.
STUDY_DIRECTOR
MacroGenics

Study Locations (Sites)

Colorado Blood Cancer Network
Denver, Colorado, 80218
United States
University of Maryland, Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
START - Midwest
Grand Rapids, Michigan, 49503
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
South Austin Medical Center
Austin, Texas, 78704
United States

Collaborators and Investigators

Sponsor: MacroGenics

  • Ashley Ward, M.D., STUDY_DIRECTOR, MacroGenics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-07-13
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • 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