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
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,
⁃ 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.