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NCT05362773 · ClinicalTrials.gov registry record · Phase 1
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 1 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by MacroGenics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
- 7
- Study locations
NCT05362773: Recruiting Phase 1 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, sponsored by MacroGenics.
NCT05362773 is a Phase 1 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia that is actively recruiting participants, run by MacroGenics. The registered enrollment target is 130 participants, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05362773, a Phase 1 study of Myelodysplastic Syndromes and Chronic Myeloid Leukemia, is actively recruiting participants, sponsored by MacroGenics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Observation of side effects determines the highest safe dose for further study
Conditions Studied
Interventions
- DRUG MGD024
Study Locations (7)
Colorado
- Colorado Blood Cancer Network - Denver
Maryland
- University of Maryland, Greenbaum Comprehensive Cancer Center - Baltimore
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- START - Midwest - Grand Rapids
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Duke University Medical Center - Durham
Texas
- South Austin Medical Center - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT05362773 shows while recruiting
NCT05362773 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (54% lower).
The record links to 8 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which MGD024 is the first listed.
NCT05362773 lists 7 locations in 7 states (Colorado, Maryland, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05362773 about?
NCT05362773 is a clinical study titled "A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies". 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, pharmacokine...
What is the current status of trial NCT05362773?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2022-07-13. Estimated completion is 2027-05.
What conditions does trial NCT05362773 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Chronic Myeloid Leukemia, Classical Hodgkin Lymphoma, Blastic Plasmacytoid Dendritic Cell Neoplasm, Leukemia, B-cell.
What interventions are being tested in trial NCT05362773?
The interventions under investigation include: MGD024 (DRUG).
Who is sponsoring clinical trial NCT05362773?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05362773 being conducted?
This trial has 7 study locations across Colorado, Maryland, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05362773's enrollment target sits among peer trials
130 43rd of 173 higher than 130 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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