A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

MacroGenics

Status and phase

Enrolling

Phase 1

Conditions

Leukemia, B-cell

Mastocytosis, Aggressive Systemic

Leukemia, Acute Myeloid

Leukemia, Hairy Cell

Chronic Myeloid Leukemia

Blastic Plasmacytoid Dendritic Cell Neoplasm

Classical Hodgkin Lymphoma

Myelodysplastic Syndromes

Treatments

Drug: MGD024

Study type

Interventional

Funder types

Industry

Identifiers

NCT05362773

CP-MGD024-01

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.