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.
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,
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
Sequential
MGD024
DrugMGD024 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
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.
Observation of side effects determines the highest safe dose for further study
Mean maximum concentration
The highest concentration of MGD024 at the end of the infusion
Mean area under the concentration-time curve (AUC)
Total body exposure to MGD024
Number of participants with anti-drug antibody formation
Number of patients who develop antibodies against MDG024
Overall response rate
The proportion of patients with a complete response or a partial response to treatment
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