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
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.
Arms & 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.
Outcome measures
Primary
Number of severe side effects in patients receiving MGD024
Observation of side effects determines the highest safe dose for further study
Time frame: 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
Time frame: Throughout study participation, up to 12 months.
Secondary
Mean maximum concentration
Time frame: Throughout study participation, up to 12 months.
Mean area under the concentration-time curve (AUC)
Time frame: Throughout study participation, up to 12 months.
Number of participants with anti-drug antibody formation
Time frame: Throughout study participation, up to 12 months.
Overall response rate
Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Complete response rate
Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Median progression free survival
Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.Assessed from Day 1 throughout the study until individual participant discontinuation, up to 12 months. Survival from Day 1 throughout the study.
Median time to response
Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Median duration of response
Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Overall survival
Time frame: Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.
Number of participants with AEs and SAEs occurring after administration of tocilizumab or etanercept for cytokine release syndrome (CRS)
Time frame: Throughout study participation, up to 12 months.
Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab or etanercept
Time frame: Throughout study participation, up to 12 months.
Outcome of CRS event in participants treated with tocilizumab or etanercept
Time frame: Throughout study participation, up to 12 months.
Eligibility criteria
Study locations (7)
Colorado Blood Cancer Network
Denver, Colorado, 80218
University of Maryland, Greenbaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
START - Midwest
Grand Rapids, Michigan, 49503
Washington University School of Medicine
St Louis, Missouri, 63110
Duke University Medical Center
Durham, North Carolina, 27710
South Austin Medical Center
Austin, Texas, 78704