Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

February 14, 2026 updated by: National Heart, Lung, and Blood Institute (NHLBI)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: epcoritamab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
Time Frame: 25 days (Cycle 1 Day 25)
25 days (Cycle 1 Day 25)

Secondary Outcome Measures

Outcome Measure
Time Frame
Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
Time Frame: 167 Days (Cycle 7 Day 1)
167 Days (Cycle 7 Day 1)
DNA sequencing of tumor cells
Time Frame: 167 Days (Cycle 7 Day 1)
167 Days (Cycle 7 Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Adrian U Wiestner, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

July 18, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 11, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10001671
  • 001671-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available by the end of the project/protocol or at the time of associated publication, whichever comes first.

IPD Sharing Access Criteria

BioData Catalyst is supported by NHLBI and access to data is controlled by the NHLBI Data Access Committee (DAC) utilizing the database of Genotypes and Phenotypes (dbGaP) permissions infrastructure. In order to access controlled-access data in BioData Catalyst, an investigator must have an approved Data Access Request (DAR) in dbGaP.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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