Leukemia, Chronic LymphocyticPhase 1NCT06676033
Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
A Phase 1 study testing epcoritamab in people with Leukemia, Chronic Lymphocytic and Richter Syndrome, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Leukemia, Chronic Lymphocytic, Richter Syndrome
- What is being tested?
- epcoritamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2025to 1 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
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 detailed 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
- Conditions
- Leukemia, Chronic Lymphocytic, Richter Syndrome
- Being tested
- epcoritamab
- Keywords
- Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epcoritamabDrug
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
| Study group | Role | What they receive |
|---|---|---|
| epcoritamab | Experimental | Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected. Receives: Drug: epcoritamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Measured: 25 days (Cycle 1 Day 25)
Secondary outcomes (2)
Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
Measured: 167 Days (Cycle 7 Day 1)
DNA sequencing of tumor cells
Measured: 167 Days (Cycle 7 Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start18 Jul 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Chronic LymphocyticStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Adrian U Wiestner, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676033
- Sponsor's protocol ID
- 10001671
- Other IDs
- 001671-H
- Status last verified
- 6 Jul 2026
- First submitted
- 5 Nov 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
- ClinicalTrials.gov ID
- NCT06676033
- Acronym / sponsor ID
- 10001671
- Conditions
- Leukemia, Chronic Lymphocytic, Richter Syndrome
- Keywords
- Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epcoritamab | Experimental | Drug: epcoritamabSamples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epcoritamabSamples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected. | Drug | epcoritamab |
Primary outcome
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Time frame: 25 days (Cycle 1 Day 25)
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian U Wiestner, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing epcoritamab in people with Leukemia, Chronic Lymphocytic and Richter Syndrome, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow (time frame: 25 days (Cycle 1 Day 25)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.