Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Phase 1

Recruiting

• Conditions: Leukemia, Chronic Lymphocytic; Richter Syndrome
• Interventions: Drug: epcoritamab

• Registration Number: NCT06676033
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief 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. 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 Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-06
• Status Verified: 2025-03-14
• Last Update Submitted: 2025-07-10
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-16
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
epcoritamab	epcoritamab	Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.

Primary Outcome Measures

Name	Time	Method
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow	25 days (Cycle 1 Day 25)

Secondary Outcome Measures

Name	Time	Method
Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood	167 Days (Cycle 7 Day 1)
DNA sequencing of tumor cells	167 Days (Cycle 7 Day 1)

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States