A Phase 1 interventional study of epcoritamab in Leukemia, Chronic Lymphocytic and Richter Syndrome, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 1, Interventional, and Basic science
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.
Study Description:
Subjects enrolled in GCT3013-03, a phase 1b/2 study of epcoritamab in R/R CLL and RS, at the National Institutes of Health (NIH) Clinical Center (CC) will be invited to simultaneously participate in this companion correlative study. Subjects will undergo percutaneous lymph node coreneedle biopsies, bone marrow biopsies, lymphapheresis, and blood draws for pharmacodynamic evaluation of tumor and immune cells in affected tissue sites and blood before and during treatment with epcoritamab.
Objectives:
Primary Objective:
-Assess the pharmacodynamic effects of epcoritamab in the tumor microenvironment.
Secondary Objectives:
Exploratory Objective:
-Evaluate pharmacodynamic and predictive biomarkers
Endpoints:
Primary Endpoint:
-Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Secondary Endpoints:
Exploratory Endpoints:
-Tests include, but are not limited to single cell multiomics, bulk lymph node transcriptome cytokine analysis
1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.
This study's enrollment of 5 is below the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
None
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
Drug: epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Time frame: 25 days (Cycle 1 Day 25)
Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
Time frame: 167 Days (Cycle 7 Day 1)
DNA sequencing of tumor cells
Time frame: 167 Days (Cycle 7 Day 1)
Plan to share: Yes — The clinical components of this project will generate data as specified by the clinical protocols, including patient demographics, tumor characteristics, treatment administration, and response, adverse events, and other primary/secondary outcomes. Data will be collected from all enrolled research participants. To protect research participant identities, individual de-identified data points will be made available for sharing. protocol-related clinical data as generated above will be preserved as specified by the clinical protocol. Shared data will be limited to that specified within the protocol informed consent. Shared data will be aggregated as necessary to ensure deidentification of the data in accordance with applicable legal and regulatory requirements governing human subjects' research.
Supporting information: Study protocol, Icf
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell→
National Heart, Lung, and Blood Institute (NHLBI)