Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
epcoritamab
Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.
干预措施: epcoritamab (Drug)
结局指标
主要结局
Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow
时间窗: 25 days (Cycle 1 Day 25)
次要结局
- 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))