Genmab_Study of Epcoritamab in Subjects with R/R Chronic Lymphocytic Leukemia & Richter's Syndrome

What is the 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.

What is the Condition Being Studied?

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) and Richter's Syndrome

Who Can Participate in the Study?

Adults who:

  • Are diagnosed with Relapsed or Refractory CLL with Richter's Syndrome
  • Have tried at least 2 lines of previous therapy, including treatment with a BTK inhibitor
  • Are taking prophylaxis for tumor lysis syndrome
  • Are not eligible or unwilling to receive aggressive chemotherapy
  • Have never been treated with a CD3 x CD20 bispecific antibody
  • Have never received an organ or stem cell transplant

For more information about who can join this study, please contact the study team at 919-681-6580.

Age Group
Adults

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:

  • Have a physical exam
  • Have a heart scan (ECG)
  • Have blood draws

After the screening period, if you are eligible, you will receive the study drug in the following manner:

  • Study drug cycles 1-3: one injection of the study drug on days 1, 8, 15 and 22 of each cycle
  • Study drug cycles 4-9: one injection of the study drug every on days 1 and 15 of each cycle
  • Study drug cycle 10 and onwards: one injection of the study drug on day 1 of each cycle

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
Assistant Professor of Medicine
Protocol Number
IRB: PRO00112885
NCT: NCT04623541
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL