MGD024 for Myelodysplastic Syndromes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana Farber Cancer Institute, Boston, MA
Myelodysplastic Syndromes+14 More
MGD024 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Myelodysplastic Syndromes
  • leukemia
  • Mastocytosis, Aggressive Systemic
  • Classical Hodgkin's Lymphoma
  • Leukemia, Myelocytic, Acute
  • Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
  • Leukemia, Hairy Cell

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Throughout study participation, up to 12 months.

Month 12
Overall survival
Day 1
Area under the concentration-time curve (AUC)
Maximum concentration
Month 12
Anti-drug antibody formation
Month 12
Complete response rate
Overall response rate
Month 12
Duration of response
Time to response
Month 12
Progression free survival
Day 28
Number of severe side effects in patients receiving MGD024
Month 12
Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Number of participants with AEs and SAEs occurring after administration of tocilizumab
Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab.

Trial Safety

Safety Progress

1 of 3

Other trials for Myelodysplastic Syndromes

Trial Design

1 Treatment Group

Dose Escalation
1 of 1
Experimental Treatment

90 Total Participants · 1 Treatment Group

Primary Treatment: MGD024 · No Placebo Group · Phase 1

Dose Escalation
Drug
Experimental Group · 1 Intervention: MGD024 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout study participation, up to 12 months.
Closest Location: Dana Farber Cancer Institute · Boston, MA
Photo of dana farber cancer institute 1Photo of dana farber cancer institute 2Photo of dana farber cancer institute 3
2004First Recorded Clinical Trial
37 TrialsResearching Myelodysplastic Syndromes
542 CompletedClinical Trials

Who is running the clinical trial?

MacroGenicsLead Sponsor
44 Previous Clinical Trials
5,105 Total Patients Enrolled
1 Trials studying Myelodysplastic Syndromes
25 Patients Enrolled for Myelodysplastic Syndromes
Ashley Ward, M.D.Study DirectorMacroGenics
1 Previous Clinical Trials
150 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are at least 18 years of age
Expression of CD123 in mast cells is a prerequisite for their degranulation.
You have a performance status of ≤ 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.