Study of VIP943 in Subjects With Advanced CD123+ Hematologic Malignancies
Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring ADC, Hematologic Malignancies, Leukemia, CD123, B-ALL, AML, MDS, Relapsed/ Refractory, Hematologic Diseases, Bone Marrow Diseases
Eligibility Criteria
Inclusion Criteria: Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity. Evidence of CD123 expression from a local laboratory. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: Known central nervous system (CNS) metastases and/or carcinomatous meningitis. Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
Sites / Locations
- TriStar Bone Marrow TransplantRecruiting
Arms of the Study
Arm 1
Experimental
Dose Escalation of VIP943
Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW).