NCT05362773Active, not recruitingPhase 1
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 2 May 2022
- Start date
- 13 Jul 2022
- Primary completion date
- Nov 2026
- Lead sponsor
- MacroGenics
- Diseases
- Chronic myeloid leukaemia, Myelodysplastic syndromes, Chronic lymphocytic leukaemia, Acute myeloid leukemia
- NCT number
- NCT05362773
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 130
- From 13 Jul 2022 to the primary completion date, Nov 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).
- 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.
Other illness
- Known involvement of central nervous system (CNS) by the disease under investigation.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Austin Medical Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| University of Maryland Greenbaum Comprehensive Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Colorado Blood Cancer Network Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| START | Midwest Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.