Back to resultsA Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
Primary Purpose
Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MGD024
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Acute Myeloid
Eligibility Criteria
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.
Sites / Locations
- Colorado Blood Cancer NetworkRecruiting
- University of Maryland, Greenbaum Comprehensive Cancer CenterRecruiting
- Dana Farber Cancer Institute
- START - MidwestRecruiting
- Washington University School of MedicineRecruiting
- Duke University Medical Center
- South Austin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation
Arm Description
Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
Outcomes
Primary Outcome Measures
Number of severe side effects in patients receiving MGD024
Observation of side effects determines the highest safe dose for further 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
Secondary Outcome Measures
Maximum concentration
The highest concentration of MGD024 at the end of the infusion
Area under the concentration-time curve (AUC)
Total body exposure to MGD024
Anti-drug antibody formation
Number of patients who develop antibodies against MDG024
Overall response rate
The proportion of patients with a complete response or a partial response to treatment
Complete response rate
The proportion of patient achieving a complete response according to disease-specific criteria
Progression free survival
The time between the first dose date to the date of first documented disease-specific progression or death from any cause
Time to response
The time between the first dose and the date of initial response.
Duration of response
The time between the date of initial response to the date of disease-specific progression or death from any cause
Overall survival
The time between the first dose date to the date of death from any cause
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05362773
Brief Title
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma, Leukemia, B-cell, Leukemia, Hairy Cell, Mastocytosis, Aggressive Systemic, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
Intervention Type
Drug
Intervention Name(s)
MGD024
Intervention Description
MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
Primary Outcome Measure Information:
Title
Number of severe side effects in patients receiving MGD024
Description
Observation of side effects determines the highest safe dose for further study
Time Frame
First 28 days of the study
Title
Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
Description
Observation of side effects determines the highest safe dose for further study
Time Frame
Throughout study participation, up to 12 months.
Secondary Outcome Measure Information:
Title
Maximum concentration
Description
The highest concentration of MGD024 at the end of the infusion
Time Frame
Day 1, 8,15, 22, 29, 36, 43, 50 and 57
Title
Area under the concentration-time curve (AUC)
Description
Total body exposure to MGD024
Time Frame
Day 1, 8,15, 22, 29, 36, 43, 50 and 57
Title
Anti-drug antibody formation
Description
Number of patients who develop antibodies against MDG024
Time Frame
Day 1, Day 15, Day 28, then every 28 days throughout the study, up to 12 months.
Title
Overall response rate
Description
The proportion of patients with a complete response or a partial response to treatment
Time Frame
Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Title
Complete response rate
Description
The proportion of patient achieving a complete response according to disease-specific criteria
Time Frame
Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.
Title
Progression free survival
Description
The time between the first dose date to the date of first documented disease-specific progression or death from any cause
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.
Title
Time to response
Description
The time between the first dose and the date of initial response.
Time Frame
Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Title
Duration of response
Description
The time between the date of initial response to the date of disease-specific progression or death from any cause
Time Frame
Disease response is assessed approximately every 56 days throughout the study, up to 12 months.
Title
Overall survival
Description
The time between the first dose date to the date of death from any cause
Time Frame
Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.
Title
Number of participants with AEs and SAEs occurring after administration of tocilizumab
Time Frame
Throughout study participation, up to 12 months.
Title
Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab.
Time Frame
Throughout study participation, up to 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Global Trial Manager
Phone
301-251-5172
Email
info@macrogenics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Ward, M.D.
Organizational Affiliation
MacroGenics
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Blood Cancer Network
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland, Greenbaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Winer, MD
Email
EricS_Winer@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Morgan Johnson
Email
Morgan_Johnson@DFCI.HARVARD.EDU
Facility Name
START - Midwest
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
South Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
We'll reach out to this number within 24 hrs