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

Study Purpose

CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in patients 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. Patients 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. Patients will be checked for side effects throughout the study.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.

- Patients with primary or secondary acute myeloid leukemia (AML), primary or secondary myelodysplastic syndrome (MDS), 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05362773
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	MacroGenics
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ashley Ward, M.D.
Principal Investigator Affiliation	MacroGenics
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma, Leukemia, B-cell, Leukemia, Hairy Cell, Mastocytosis, Aggressive Systemic, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia

Arms & Interventions

Arms

Experimental: Dose Escalation

Escalating doses of MGD024 will be assigned based on safety and tolerability of the previous dose level.

Interventions

Drug: - MGD024

MGD024 is a CD123 x CD3 bispecific DART® molecule designed to target CD123-expressing leukemic cells for elimination by CD3-expressing T lymphocytes.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Colorado Blood Cancer Network, Denver, Colorado

Status

Recruiting

Address

Colorado Blood Cancer Network

Denver, Colorado, 80218

Site Contact

[email protected]

301-251-5172

Baltimore, Maryland

Status

Recruiting