Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called epcoritamab (the study drug). We want to know how well this study drug works in people with relapsed/refractory CLL and Richter's Syndrome.
Who Can Participate?
Eligibility
Adults who:<ul>
<li>Are diagnosed with Relapsed or Refractory CLL with Richter's Syndrome</li>
<li>Have tried at least 2 lines of previous therapy, including treatment with a BTK inhibitor</li>
<li>Are taking prophylaxis for tumor lysis syndrome</li>
<li>Are not eligible or unwilling to receive aggressive chemotherapy</li>
<li>Have never been treated with a CD3 x CD20 bispecific antibody</li>
<li>Have never received an organ or stem cell transplant</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6580.
<li>Are diagnosed with Relapsed or Refractory CLL with Richter's Syndrome</li>
<li>Have tried at least 2 lines of previous therapy, including treatment with a BTK inhibitor</li>
<li>Are taking prophylaxis for tumor lysis syndrome</li>
<li>Are not eligible or unwilling to receive aggressive chemotherapy</li>
<li>Have never been treated with a CD3 x CD20 bispecific antibody</li>
<li>Have never received an organ or stem cell transplant</li></ul>
For more information about who can join this study, please contact the study team at 919-681-6580.
What is Involved?
If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
After the screening period, if you are eligible, you will receive the study drug in the following manner:<ul>
<li>Study drug cycles 1-3: one injection of the study drug on days 1, 8, 15 and 22 of each cycle</li>
<li>Study drug cycles 4-9: one injection of the study drug every on days 1 and 15 of each cycle</li>
<li>Study drug cycle 10 and onwards: one injection of the study drug on day 1 of each cycle</li></ul>
Each drug cycle in the study is a period of 28 days. The study will run for approximately 5 years. You may continue receiving the study drugs as long as the doctor thinks you are benefitting.
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li></ul>
After the screening period, if you are eligible, you will receive the study drug in the following manner:<ul>
<li>Study drug cycles 1-3: one injection of the study drug on days 1, 8, 15 and 22 of each cycle</li>
<li>Study drug cycles 4-9: one injection of the study drug every on days 1 and 15 of each cycle</li>
<li>Study drug cycle 10 and onwards: one injection of the study drug on day 1 of each cycle</li></ul>
Each drug cycle in the study is a period of 28 days. The study will run for approximately 5 years. You may continue receiving the study drugs as long as the doctor thinks you are benefitting.
Study Details
Full Title
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3 X CD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter?s Syndrome
Principal Investigator
Andrea
Sitlinger
Protocol Number
PRO00112885
NCT ID
NCT04623541
Phase
I/II
Enrollment Status
Open to Enrollment