NCT05362773 A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
| NCT ID | NCT05362773 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | MacroGenics |
| Condition | Leukemia, Acute Myeloid |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2022-07-13 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2022-07-13 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frank Perabo, MD, PhD
STUDY DIRECTOR
MacroGenics
Frequently Asked Questions
Who can join the NCT05362773 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Leukemia, Acute Myeloid. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05362773 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05362773 currently recruiting?
Yes, NCT05362773 is actively recruiting participants. Contact the research team at info@macrogenics.com for enrollment information.
Where is the NCT05362773 trial being conducted?
This trial is being conducted at Denver, United States, Baltimore, United States, Boston, United States, Grand Rapids, United States and 3 additional locations.
Who is sponsoring the NCT05362773 clinical trial?
NCT05362773 is sponsored by MacroGenics. The principal investigator is Frank Perabo, MD, PhD at MacroGenics. The trial plans to enroll 130 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.