Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

The purpose of this study is to evaluate the clinical safety and preliminary efficacy of tafasitamab (MOR208) combined with idelalisib or venetoclax. The study will include safety run-in phase for each cohort with an evaluation of the safety data by an Independent Data Monitoring Committee.

An optional sub-study has been introduced to collect biological samples for investigations on biomarkers (e.g., CD19 expression) after tafasitamab treatment.

Major inclusion criteria

Diagnosis/Trial Population

• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):

• history of diagnosis of CLL or SLL that meets IWCLL diagnostic criteria
• histologically confirmed diagnosis of SLL by lymph node biopsy
• indication for treatment as defined by the IWCLL guidelines
• Patients must have both of the following:

• relapsed or refractory disease while receiving a BTKi therapy or intolerance of such therapy
• single-agent or combination therapy with a BTKi for at least one month must be the patient's most recent prior anticancer therapy
• ECOG performance status of 0 to 2
• Patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery

Laboratory Values

• Patients must meet adequate bone marrow function and adequate hepatic and renal function

Other Inclusion Criteria

• Females of childbearing potential must use a highly effective method of contraception

Major exclusion criteria

Diagnosis

• Patients who have:

• non-Hodgkin's lymphomas other than CLL/SLL
• transformed CLL/SLL or Richter's syndrome
• active and uncontrolled autoimmune cytopenia

Previous and Current Treatment

• Patients who have received treatment with a BTK inhibitor within 5 days prior to Day 1 dosing
• Patients who have, within 14 days prior to D1 dosing:

• not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
• systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease
• received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases