A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT05362773|
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : May 8, 2023
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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.
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: MGD024||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 13, 2022|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
Experimental: Dose Escalation
Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.
- Number of severe side effects in patients receiving MGD024 [ Time Frame: First 28 days of the study ]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. [ Time Frame: Throughout study participation, up to 12 months. ]Observation of side effects determines the highest safe dose for further study
- Maximum concentration [ Time Frame: Day 1, 8,15, 22, 29, 36, 43, 50 and 57 ]The highest concentration of MGD024 at the end of the infusion
- Area under the concentration-time curve (AUC) [ Time Frame: Day 1, 8,15, 22, 29, 36, 43, 50 and 57 ]Total body exposure to MGD024
- Anti-drug antibody formation [ Time Frame: Day 1, Day 15, Day 28, then every 28 days throughout the study, up to 12 months. ]Number of patients who develop antibodies against MDG024
- Overall response rate [ Time Frame: 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 [ Time Frame: 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
- 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. ]The time between the first dose date to the date of first documented disease-specific progression or death from any cause
- Time to response [ Time Frame: 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 initial response.
- Duration of response [ Time Frame: 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 [ Time Frame: 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 AEs and SAEs occurring after administration of tocilizumab [ Time Frame: Throughout study participation, up to 12 months. ]
- 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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05362773
|Contact: Global Trial Manageremail@example.com|
|United States, Colorado|
|Colorado Blood Cancer Network||Recruiting|
|Denver, Colorado, United States, 80218|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Eric Winer, MD EricS_Winer@DFCI.HARVARD.EDU|
|Contact: Morgan Johnson Morgan_Johnson@DFCI.HARVARD.EDU|
|United States, Michigan|
|South Texas Accelerated Research Therapeutics, LLC - Midwest||Recruiting|
|Grand Rapids, Michigan, United States, 49503|
|United States, Missouri|
|washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|South Austin Medical Center||Recruiting|
|Austin, Texas, United States, 78704|
|Study Director:||Ashley Ward, M.D.||MacroGenics|
|Other Study ID Numbers:||
|First Posted:||May 5, 2022 Key Record Dates|
|Last Update Posted:||May 8, 2023|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Acute
Leukemia, Hairy Cell
Neoplasms by Histologic Type
Bone Marrow Diseases
Immune System Diseases
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Mast Cell Activation Disorders