Spots Global Cancer Trial Database for A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
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Trial Identification
Brief Title: A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
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
Study ID: NCT05362773
Interventions
Study Description
Brief Summary: CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in patients 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. Patients 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. Patients will be checked for side effects throughout the study.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint Louis, Missouri, United States
Duke University Medical Center, Durham, North Carolina, United States
South Austin Medical Center, Austin, Texas, United States
Contact Details
Name: Ashley Ward, M.D.
Affiliation: MacroGenics
Role: STUDY_DIRECTOR
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