RECRUITING

Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Quick Facts

Study Start:2025-02-19
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06676033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be undergoing screening for GCT3013-03
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Ability of subject to understand and the willingness to sign a written informed consent document.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Ingrid C Frey
CONTACT
(301) 402-0797
ingrid.frey@nih.gov
Clare C Sun, M.D.
CONTACT
(301) 402-1806
clare.sun@nih.gov

Principal Investigator

Clare C Sun, M.D.
PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

  • Clare C Sun, M.D., PRINCIPAL_INVESTIGATOR, National Heart, Lung, and Blood Institute (NHLBI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-19
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2025-02-19
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker

Additional Relevant MeSH Terms

  • Leukemia, Chronic Lymphocytic
  • Richter Syndrome