Dose-finding Trial of HCD122 in Patients With Chronic Lymphocytic Leukemia (CLL) That is Relapsed or Non-responsive to Prior Fludaribine Therapy

An Open-label,Multi-center, Phase l/ll Study of Anti-CD40 Monoclonal Antibody (HCD122) Administered Intravenously to Subjects With Advanced Chronic Lymphocytic Leukemia That is Refractory or Relapsed After at Least One Previous Fludarabine-containing Chemotherapy Regimen

The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with chronic lymphocytic leukemia who are relapsed after receiving prior treatment.

Inclusion Criteria:

• Clinical diagnosis of CLL requiring treatment
• Refractory or relapsed disease
• Prior treatment with fludarabine
• Male or Female
• >18 years of age

Exclusion Criteria:

• Treatment with rituximab within 90 days and alemtuzumab or any monoclonal antibody within 6 months.
• Clinically significant cardiac dysfunction or other significant organ dysfunction

Additional eligibility criteria apply that will be reviewed with potential study subjects at the site.