This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients completing the study treatment are invited to participate in an optional biomarker sub-study.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
idelalisib dose: 150 mg twice daily orally
venetoclax dose: 400 mg once daily orally
Clinical Study Site
Jacksonville, Florida, United States
Clinical Study Site
Rochester, Minnesota, United States
Clinical Study Site
Columbus, Ohio, United States
Clinical Study Site
Graz, Austria
Clinical Study Site
Salzburg, Austria
Clinical Study Site
Vienna, Austria
Clinical Study Site
Dresden, Germany
Clinical Study Site
Leipzig, Germany
Clinical Study Site
München, Germany
Clinical Study Site
Brescia, Italy
...and 7 more locations
Incidence and Severity of Adverse Events (AEs)
For details please see Section of Adverse Events Overview
Time frame: 2 years
Best Objective Response Rate (ORR)
ORR = complete response \[CR\] + partial response \[PR\]; Local Evaluation
Time frame: 2 years
Number of Participants With Treatment-emergent or Treatment-boosted Anti-MOR00208 Antibody Formation
Number of participants with treatment-emergent or treatment-boosted anti-MOR00208 (anti-tafasitamab) antibody formation
Time frame: 2 years
Maximum Plasma Concentration (Cmax) of MOR00208
Mean Cmax of tafasitamab (MOR00208) at Cycle 3 Day 15 (after the weekly dosing of tafasitamab in Cycles 1 to 3 including a loading dose at C1D4)
Time frame: At Cycle 3 Day 15
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