Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
NCT ID: NCT06676033
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-07-18
2027-07-01
Brief Summary
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The study is enrolling by invitation only.
Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
Interventions
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epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
Eligibility Criteria
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Inclusion 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
18 Years
100 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Responsible Party
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Principal Investigators
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Adrian U Wiestner, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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001671-H
Identifier Type: -
Identifier Source: secondary_id
10001671
Identifier Type: -
Identifier Source: org_study_id