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

Part of paid clinical trials in Denver, Colorado.

Sponsor
MacroGenics
Study ID
NCT05362773
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 13, 2022
Status verified
May 2026
Primary completion
Nov 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.

Primary Outcome Measure

Number of severe side effects in patients receiving MGD024 [ Time Frame: First 28 days of the study ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer NetworkDenverColorado80218-
University of Maryland, Greenbaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Dana Farber Cancer InstituteBostonMassachusetts02215
Eric Winer, MD
START - MidwestGrand RapidsMichigan49503-
Washington University School of MedicineSt LouisMissouri63110-
Duke University Medical CenterDurhamNorth Carolina27710-
South Austin Medical CenterAustinTexas78704-

Find similar trials in Denver, CO

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Colorado Blood Cancer Network· Denver, COUniversity of Maryland, Greenbaum Comprehensive Cancer Center· Baltimore, MDDana Farber Cancer Institute· Boston, MASTART - Midwest· Grand Rapids, MIWashington University School of Medicine· St Louis, MODuke University Medical Center· Durham, NC

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