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

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

Es posible que algunos contenidos no estén disponibles en español.

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:
  • 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.

What is Involved?

Description

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

Andrea
Sitlinger

Protocol Number

PRO00112885

NCT ID

NCT04623541

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov