Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT06676033
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:
NCT06676033
Study Brief:
Protocol Section:
NCT06676033