Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This correlative study aims to understand the pharmacodynamic effects and clonal dynamics in response to epcoritamab by obtaining and analyzing lymph node, bone marrow, and blood samples from subjects enrolled in GCT3013-03 trial sponsored by Genmab at NIH. Samples will be collected before and at multiple time points during treatment with epcoritamab. National Heart, Lung, and Blood Institute (NHLBI) investigators are experienced in testing samples treated with bsAb2,3 including epcoritamab in an ongoing pre-clinical collaboration with Genmab. Addressing the objectives of this correlative study will advance the science and clinical application of epcoritamab specifically as well as T-cell engaging bsAb in general as an emerging class of immunotherapy for cancer. The study is enrolling by invitation only.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Must be undergoing screening for GCT3013-03

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Ability of subject to understand and the willingness to sign a written informed consent document.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Ingrid C Frey
ingrid.frey@nih.gov
(301) 402-0797
Backup
Clare C Sun, M.D.
clare.sun@nih.gov
(301) 402-1806
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 30
Treatments
Experimental: epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
Sponsors
Leads: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov