Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blastic Plasmacytoid Dendritic Cell Neoplasm | Blastic Plasmacytoid Dendritic Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Classical Hodgkin Lymphoma | Classic Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
| Leukemia, Acute Myeloid | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Leukemia, B-cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Hairy Cell | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
| Mastocytosis, Aggressive Systemic | Aggressive Systemic Mastocytosis | ONTOLOGY_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGD024 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.
- interventionNames
- Drug: MGD024
Primary outcomes (2)
- measure
- Number of severe side effects in patients receiving MGD024
- timeFrame
- First 28 days of the study
- description
- Observation of side effects determines the highest safe dose for further study
- measure
- Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.
- timeFrame
- Throughout study participation, up to 12 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available