Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL

The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.

Inclusion Criteria:

• Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
• Refractory to or relapsed after at least 1 prior treatment regimen
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

• Any major surgery, chemotherapy or immunotherapy within the last 14 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)