A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
- Conditions
- Leukemia, Acute MyeloidMyelodysplastic SyndromesClassical Hodgkin LymphomaLeukemia, B-cellLeukemia, Hairy CellMastocytosis, Aggressive SystemicBlastic Plasmacytoid Dendritic Cell NeoplasmChronic Myeloid Leukemia
- Interventions
- Registration Number
- NCT05362773
- Lead Sponsor
- MacroGenics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation MGD024 Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
- Primary Outcome Measures
Name Time Method Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation. Throughout study participation, up to 12 months. Observation of side effects determines the highest safe dose for further study
Number of severe side effects in patients receiving MGD024 First 28 days of the study Observation of side effects determines the highest safe dose for further study
- Secondary Outcome Measures
Name Time Method Mean maximum concentration Throughout study participation, up to 12 months. The highest concentration of MGD024 at the end of the infusion
Mean area under the concentration-time curve (AUC) Throughout study participation, up to 12 months. Total body exposure to MGD024
Number of participants with anti-drug antibody formation Throughout study participation, up to 12 months. Number of patients who develop antibodies against MDG024
Outcome of CRS event in participants treated with tocilizumab or etanercept Throughout study participation, up to 12 months. Overall response rate Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months. The proportion of patients with a complete response or a partial response to treatment
Complete response rate Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months. The proportion of patient achieving a complete response according to disease-specific criteria
Number of participants with AEs and SAEs occurring after administration of tocilizumab or etanercept for cytokine release syndrome (CRS) Throughout study participation, up to 12 months. Median progression free survival 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. The time between the first dose date to the date of first documented disease-specific progression or death from any cause
Median time to response Disease response is assessed approximately every 56 days throughout the study, up to 12 months. The time between the first dose and the date of complete or partial response.
Median duration of response Disease response is assessed approximately every 56 days throughout the study, up to 12 months. The time between the date of initial response to the date of disease-specific progression or death from any cause
Overall survival Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months. The time between the first dose date to the date of death from any cause
Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab or etanercept Throughout study participation, up to 12 months.
Trial Locations
- Locations (7)
Colorado Blood Cancer Network
🇺🇸Denver, Colorado, United States
University of Maryland, Greenbaum Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
START - Midwest
🇺🇸Grand Rapids, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
South Austin Medical Center
🇺🇸Austin, Texas, United States