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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MGD024 | Drug | MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe side effects in patients receiving MGD024 | Observation of side effects determines the highest safe dose for further study | First 28 days of the 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 | Throughout study participation, up to 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean maximum concentration | The highest concentration of MGD024 at the end of the infusion | Throughout study participation, up to 12 months. |
| Mean area under the concentration-time curve (AUC) |
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Inclusion Criteria:
Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.
Participants with
Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.
Evidence of at least 20% of malignant cells with 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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Global Trial Manager | Contact | 301-251-5172 | info@macrogenics.com |
| Name | Affiliation | Role |
|---|---|---|
| Frank Perabo, MD, PhD | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Blood Cancer Network | Recruiting | Denver | Colorado | 80218 | United States | |
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Total body exposure to MGD024
| Throughout study participation, up to 12 months. |
| Number of participants with anti-drug antibody formation | Number of patients who develop antibodies against MDG024 | Throughout study participation, up to 12 months. |
| Overall response rate | The proportion of patients with a complete response or a partial response to treatment | Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months. |
| Complete response rate | The proportion of patient achieving a complete response according to disease-specific criteria | Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months. |
| Median progression free survival | The time between the first dose date to the date of first documented disease-specific progression or death from any cause | 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. |
| Median time to response | The time between the first dose and the date of complete or partial response. | Disease response is assessed approximately every 56 days throughout the study, up to 12 months. |
| Median duration of response | The time between the date of initial response to the date of disease-specific progression or death from any cause | Disease response is assessed approximately every 56 days throughout the study, up to 12 months. |
| Overall survival | The time between the first dose date to the date of death from any cause | Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months. |
| 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. |
| Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab or etanercept | Throughout study participation, up to 12 months. |
| Outcome of CRS event in participants treated with tocilizumab or etanercept | Throughout study participation, up to 12 months. |
| University of Maryland, Greenbaum Comprehensive Cancer Center |
| Recruiting |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| START - Midwest | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Completed | Durham | North Carolina | 27710 | United States |
| South Austin Medical Center | Recruiting | Austin | Texas | 78704 | United States |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| D015448 | Leukemia, B-Cell |
| D007943 | Leukemia, Hairy Cell |
| D034721 | Mastocytosis, Systemic |
| D000099067 | Blastic Plasmacytoid Dendritic Cell Neoplasm |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008415 | Mastocytosis |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D000090362 | Mast Cell Activation Disorders |
| D015620 | Histiocytic Disorders, Malignant |
| D008223 | Lymphoma |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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