|Exclusion Criteria:||1) History of or current central nervous system disease that might put the subject at increased risk of bleeding (e.g., thrombotic, embolic, or hemorrhagic cerebrovascular accident [CVA]; transient ischemic attack; or known aneurysm). Subjects with a history of migraines or controlled seizure disorder are not excluded. Subjects with symptoms of central nervous system (CNS) involvement (e.g., persistent headaches, confusion) must have documented absence of CNS disease by imaging scan within 4 weeks prior to Screening.|
2) Major surgical procedure within 4 weeks prior to Screening.
3) Minor procedures without complications such as placement of central venous catheters, peripherally inserted central catheter (PICC) lines, or biopsies are allowed.
4) Use of hydroxyurea or plasmapheresis within 7 days of starting treatmetn with KB004.
5) Ongoing surgical or wound healing complications
6) Active clinically significant bleeding (e.g., hemoptysis, rectal bleeding, or ulcer disease) within 4 weeks prior to Screening
7) Uncontrolled systemic hypertension (e.g., systolic blood pressure >160 mmHg, diastolic blood pressure >100 mmHg on medication)
8) Clinically significant intercurrent illness (e.g., uncontrolled systemic infection, uncontrolled disseminated intravascular coagulation, myocardial infarction, uncontrolled symptomatic coronary artery disease or congestive heart failure, need for hemodialysis, or psychiatric illness/social situations that would limit compliance with study requirements)
9) Pregnant or breastfeeding women
10) Unable to understand and unwilling to provide written informed consent
11) Known history of prolonged bleeding times or platelet dysfunction
12) Secondary primary malignancy that in the judgment of the Investigator and the Sponsor may affect study participation or interpretation of results