Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies

Protocol: OSU-16093

Full Title

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®14045 in Patients with CD123-Expressing Hematologic Malignancies

Purpose

The purpose of this study is to determine the safety and tolerability of weekly intravenous

(IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after

the first dose, and then to determine the MTD after second and subsequent infusions.

Are you eligible?

Inclusion Criteria:

Diagnosis of 1 of the following diseases:

Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but

excluding acute promyelocytic leukemia)

B-cell ALL

BPDCN

CML in blast phase, resistant or intolerant to tyrosine kinase inhibitor therapy

Patients with relapsed or refractory disease with no available standard therapy

ECOG performance status 0-2

Not a candidate for, or refusing treatment with hematopoietic stem cell

transplantation

Exclusion Criteria:

Cytotoxic chemotherapy, radiotherapy, immunotherapy or investigational agent

treatment within 2 weeks of first dose of study drug

Prior therapy with CD123- or IL-3R-directed immunotherapies, including monospecific

and bsAbs, immunoconjugates, or chimeric antigen receptor-modified T-cell therapy

Failure to recover from Grade 3 or 4 toxicity from previous treatment (unrelated to

malignant bone marrow involvement)

Known uncontrolled central nervous system involvement by malignant disease

White blood cell (WBC) count ≥10,000/mm3 or symptoms of leukostasis

Diagnosis of promyelocytic leukemia

Aspartate aminotransferase or alanine aminotransferase at screening >3.0 x upper

limit of normal (ULN) unless considered due to leukemic organ involvement

Bilirubin >1.5 x ULN, unless prior diagnosis and documentation of leukemic organ

involvement, ongoing hemolysis, or Gilbert's syndrome

Serum creatinine >2.0 x ULN, or estimated creatinine clearance <40mL/min

History or evidence of a clinically unstable/uncontrollable disorder, condition or

disease other than primary malignancy, that in the opinion of the Investigator would

pose a risk to the patient safety or interfere with the study evaluation

Evidence of any active, uncontrolled bacterial, viral, parasitic fungal infections

within 1 week of first dose of study drug

Positive test for human immunodeficiency virus (HIV) -I or -II antibodies, hepatitis

B surface antigen or core antibody, or hepatitis C virus antibody

Acute Myeloid Leukemia Chronic Myeloid Leukemia Leukemia