Purpose of this Study
We are doing this study to find out if an experimental drug called MGD024 (the study drug) is a safe and effective option for patients with different cancers of the blood or bone marrow that have relapsed or do not respond to standard therapy. We will test how the study drug works at different doses during this study in order to find the most effective dose.
Who Can Participate?
Eligibility
Adults ages 18+ who have one of the following hematologic malignancies that has either relapsed or failed to respond to therapy:<ul>
<li>Primary or secondary acute myeloid leukemia (AML); OR</li>
<li>Primary or secondary myelodysplastic syndrome (MDS); OR</li>
<li>Classic Hodgkin lymphoma (cHL); OR</li>
<li>Chronic myelogenous leukemia (CML); OR</li>
<li>B-cell acute lymphoblastic leukemia (B-ALL); OR</li>
<li>Hairy cell leukemia (HCL); OR</li>
<li>Aggressive systemic mastocytosis (ASM); OR</li>
<li>Blastic plasmacytoid dendritic cell neoplasm (BPDCN)</li></ul>
For more information about who can join this study, please contact the study team at 919-684-9220.
<li>Primary or secondary acute myeloid leukemia (AML); OR</li>
<li>Primary or secondary myelodysplastic syndrome (MDS); OR</li>
<li>Classic Hodgkin lymphoma (cHL); OR</li>
<li>Chronic myelogenous leukemia (CML); OR</li>
<li>B-cell acute lymphoblastic leukemia (B-ALL); OR</li>
<li>Hairy cell leukemia (HCL); OR</li>
<li>Aggressive systemic mastocytosis (ASM); OR</li>
<li>Blastic plasmacytoid dendritic cell neoplasm (BPDCN)</li></ul>
For more information about who can join this study, please contact the study team at 919-684-9220.
What is Involved?
If you choose to join this study and are found to be eligible after a short screening process, you will begin to receive the study drug. The study drug is given as an infusion through a vein in your arm (IV).
You will be given the study drug during 28-day periods called cycles. You will get the study drug either 2 times or 4 times per cycle. The frequency in which you receive the study drug and the dose you receive will depend on when you join the study. The study doctor will let you know your dose and how many infusions per cycle you will receive after your eligibility is confirmed.
The number of drug cycles you go through during the study will depend on how you respond to the study drug.
You will be given the study drug during 28-day periods called cycles. You will get the study drug either 2 times or 4 times per cycle. The frequency in which you receive the study drug and the dose you receive will depend on when you join the study. The study doctor will let you know your dose and how many infusions per cycle you will receive after your eligibility is confirmed.
The number of drug cycles you go through during the study will depend on how you respond to the study drug.
Study Details
Full Title
MacroGenics MGD024-01: 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
Relapsed or Refractory Hematologic Malignancies
Principal Investigator
Harry
Erba
Protocol Number
PRO00110825
NCT ID
NCT05362773
Phase
I
Enrollment Status
Open to Enrollment