Treatment with MGD024 for patients with difficult-to-treat blood cancers
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
This study is testing a new treatment called MGD024 to see if it can help adults with hard-to-treat blood cancers that haven't improved with standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MacroGenics Industry-sponsored |
| Locations | 7 sites (Denver, Colorado and 6 other locations) |
| Trial ID | NCT05362773 on ClinicalTrials.gov |
What this trial studies
This Phase 1, open-label, multi-center study evaluates the safety and effectiveness of MGD024 in adults with relapsed or refractory hematologic malignancies that have not responded to standard therapies. Participants will receive MGD024 in 28-day cycles for up to 12 cycles, with regular assessments of response and side effects. The study aims to gather data on the drug's pharmacokinetics, pharmacodynamics, and immunogenicity, as well as its preliminary anti-cancer effects.
Who should consider this trial
Good fit: Ideal candidates include adults with specific types of blood cancers who have relapsed or are refractory to previous treatments and have evidence of CD123 expression.
Not a fit: Patients with acute promyelocytic leukemia or those who have not received prior therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited treatment choices for their blood cancers.
How similar studies have performed: While this approach is novel, similar studies targeting specific blood cancers have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia, * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \>3 and \<20% bone marrow blasts, * 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 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: * 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.
Where this trial is running
Denver, Colorado and 6 other locations
- Colorado Blood Cancer Network — Denver, Colorado, United States (Recruiting)
- University of Maryland, Greenbaum Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- START - Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Completed)
- South Austin Medical Center — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Global Trial Manager
- Email: info@macrogenics.com
- Phone: 301-251-5172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.