Clinical trial NCT06676033: Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
Official title: Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Leukemia, Chronic Lymphocytic
Richter Syndrome
Keywords: Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: * 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

Primary outcomes:
measure: Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
timeFrame: 25 days (Cycle 1 Day 25)
Secondary outcomes:
measure: Immunophenotype and transcriptome of T cells and tumor cells in peripheral blood
timeFrame: 167 Days (Cycle 7 Day 1)
measure: DNA sequencing of tumor cells
timeFrame: 167 Days (Cycle 7 Day 1)
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Clare C Sun, M.D.
role: PRINCIPAL_INVESTIGATOR
References: