Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
Leukemia, Chronic Lymphocytic · Richter Syndrome
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 1
- Age range
- 18 years - 100 years
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 5 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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:
- Assess the pharmacodynamic effects of epcoritamab in blood
- Investigate clonal dynamics during treatment with epcoritamab
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:
- Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
- DNA sequencing of tumor cells
Exploratory Endpoints:
-Tests include, but are not limited to single cell multiomics, bulk lymph node transcriptome cytokine analysis
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
None
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
Drug: epcoritamab
epcoritamab DRUG
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Time frame: 25 days (Cycle 1 Day 25)
Not reported in this registry record.
Secondary measures
Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
Time frame: 167 Days (Cycle 7 Day 1)
Not reported in this registry record.
DNA sequencing of tumor cells
Time frame: 167 Days (Cycle 7 Day 1)
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesStatus unknown
Study team and timeline
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 18, 2025 Actual
- Primary completion
- Jul 1, 2027 Estimated
- Study completion
- Jul 1, 2027 Estimated
- First posted
- Nov 6, 2024 Actual
- Last updated
- Nov 9, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 9, 2026