None listed
Conditions
Interventions
Patients will receive a single intravenous infusion of KB002. The first 6 patients will be assigned to Dose Level 1 (0.2 mg/kg). If there are no dose limiting toxicities (DLTs) during the first 7 days after their infusion, the next 6 patients will be assigned to Dose level 2 (1.0 mg/kg). If there are no DLTs during the first 7 days after their infusion, the next 6 patients will be assigned to the final Dose Level 3 (5.0 mg/kg). If a DLT occurs in any dose level then an additional 3 patients
Patients will receive a single intravenous infusion of KB002. The first 6 patients will be assigned to Dose Level 1 (0.2 mg/kg). If there are no dose limiting toxicities (DLTs) during the first 7 days after their infusion, the next 6 patients will be assigned to Dose level 2 (1.0 mg/kg). If there are no DLTs during the first 7 days after their infusion, the next 6 patients will be assigned to the final Dose Level 3 (5.0 mg/kg). If a DLT occurs in any dose level then an additional 3 patients will be assigned to that dose level. Dose escalation can only occur if there are no further DLTs in the additional 3 patients.
Sponsors
KaloBios Pharmaceuticals Inc
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Willing and able to give written informed consent 2. Chronic idiopathic thrombocytopenic purpura (ITP) for at least 6 months 3. Platelet count <30 x 109/L for patients not receiving corticosteroids; < 50 x 109/L for patients receiving a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1).
Exclusion criteria
1. Treatment with cyclophosphamide, vincristine, rituximab, any other monoclonal antibody or an investigational drug within 12 weeks of Day 12. Treatment with intravenous immunoglobulin (IVIG) or intravenous Rh(D) immune globulin within 4 weeks of Day 13. Treatment with any other agent for the treatment of ITP within 4 weeks of Day 1, other than a stable dose of corticosteroids (i.e., the dose has not increased or decreased within 4 weeks of Day 1)4. Vaccination within 4 weeks of Day 15. Any of the following laboratory parameters:• WBC = 3.5 x 109/L or neutrophil count = 2.0 x 109/L• Creatinine = 2 mg/dL• Total bilirubin = 2 mg/dL• Alanine transaminase (ALT) and/or aspartate transaminase (AST) = 3 times the upper limit of normal (ULN)6. PaO2 = 95% on room air by pulse oximetry7. Major surgery, including splenectomy, within 8 weeks of Day 18. Females who are pregnant or breastfeeding9. Males or females unable to practice effective methods of birth control for 3 months after the infusion of study drug10. Current or past history of severe cardiac disease (NYHA grade III or IV, defined in Appendix B)11. Current respiratory disease or a past history of chronic respiratory disease12. Active hemolysis that requires red blood cell transfusion within 6 weeks of study entry13. History of drug-induced thrombocytopenia, marrow failure syndrome, such as aplastic anemia or myelodysplasia, or thrombocytopenia related to viral or bacterial infection14. Immune deficiency, chronic infection or chronic inflammatory condition (e.g., positive for hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] or human immunodeficiency virus [HIV], history of tuberculosis [TB], or systemic lupus erythematosus [SLE])15. History of solid or hematologic malignancy in the past 10 years, other than basal cell or non invasive squamous cell carcinoma16. Any other illness or condition that in the opinion of the investigator would be considered a high risk for participation in an investigational study, such as uncontrolled and/or clinically significant neurologic, hematologic, metabolic, endocrine, gastrointestinal, hepatic or renal disease.
Outcome results
None listed