- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05362773
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Global Trial Manager
- Phone Number: 301-251-5172
- Email: info@macrogenics.com
Study Locations
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Colorado
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Denver, Colorado, United States, 80218
- Recruiting
- Colorado Blood Cancer Network
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland, Greenbaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
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Contact:
- Eric Winer, MD
- Email: EricS_Winer@DFCI.HARVARD.EDU
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Contact:
- Morgan Johnson
- Email: Morgan_Johnson@DFCI.HARVARD.EDU
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Michigan
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Grand Rapids, Michigan, United States, 49503
- Recruiting
- START - Midwest
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine
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North Carolina
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Durham, North Carolina, United States, 27710
- Not yet recruiting
- Duke University Medical Center
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Texas
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Austin, Texas, United States, 78704
- Recruiting
- South Austin Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
- Patients with primary or secondary acute myeloid leukemia (AML), primary or secondary myelodysplastic syndrome (MDS), classical Hodgkin lymphoma (cHL), chronic myelogenous leukemia (CML), b-cell acute lymphocytic leukemia (B-ALL), hariy cell leukemia (HCL), advanced systemic mastocytosis (ASM), or blastic plasmacytoid dendritic cell neoplasm (BPDCM)
- Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
- Evidence of CD123 expression
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Life expectancy of at least 12 weeks.
- Acceptable laboratory values, and heart function.
- Continuing side effects of prior treatment are mild
- Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.
Exclusion Criteria:
- Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
- Known involvement of central nervous system (CNS) by the disease under investigation.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
- Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose
- Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation
Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
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MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of severe side effects in patients receiving MGD024
Time Frame: First 28 days of the study
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Observation of side effects determines the highest safe dose for further study
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First 28 days of the study
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Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Time Frame: Throughout study participation, up to 12 months.
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Observation of side effects determines the highest safe dose for further study
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Throughout study participation, up to 12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration
Time Frame: Day 1, 8,15, 22, 29, 36, 43, 50 and 57
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The highest concentration of MGD024 at the end of the infusion
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Day 1, 8,15, 22, 29, 36, 43, 50 and 57
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Area under the concentration-time curve (AUC)
Time Frame: Day 1, 8,15, 22, 29, 36, 43, 50 and 57
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Total body exposure to MGD024
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Day 1, 8,15, 22, 29, 36, 43, 50 and 57
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Anti-drug antibody formation
Time Frame: Day 1, Day 15, Day 28, then every 28 days throughout the study, up to 12 months.
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Number of patients who develop antibodies against MDG024
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Day 1, Day 15, Day 28, then every 28 days throughout the study, up to 12 months.
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Overall response rate
Time Frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
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The proportion of patients with a complete response or a partial response to treatment
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Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
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Complete response rate
Time Frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
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The proportion of patient achieving a complete response according to disease-specific criteria
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Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
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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.
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The time between the first dose date to the date of first documented disease-specific progression or death from any cause
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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.
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Time to response
Time Frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
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The time between the first dose and the date of initial response.
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Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
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Duration of response
Time Frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
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The time between the date of initial response to the date of disease-specific progression or death from any cause
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Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
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Overall survival
Time Frame: Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.
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The time between the first dose date to the date of death from any cause
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Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.
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Number of participants with AEs and SAEs occurring after administration of tocilizumab
Time Frame: Throughout study participation, up to 12 months.
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Throughout study participation, up to 12 months.
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Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab.
Time Frame: Throughout study participation, up to 12 months.
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Throughout study participation, up to 12 months.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ashley Ward, M.D., MacroGenics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Leukemia, Lymphoid
- Neoplasms, Connective Tissue
- Leukemia, Myeloid
- Chronic Disease
- Mast Cell Activation Disorders
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, B-Cell
- Mastocytosis
- Mastocytosis, Systemic
- Leukemia, Hairy Cell
Other Study ID Numbers
- CP-MGD024-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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