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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
14mo left

Started Jul 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jul 2025Jul 2027

First Submitted

Initial submission to the registry

November 5, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

July 18, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

February 17, 2026

Status Verified

February 11, 2026

Enrollment Period

2 years

First QC Date

November 5, 2024

Last Update Submit

February 14, 2026

Conditions

Leukemia, Chronic LymphocyticRichter Syndrome

Keywords

Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker

Outcome Measures

Primary Outcomes (1)

  • Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow

    25 days (Cycle 1 Day 25)

Secondary Outcomes (2)

  • 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)

Study Arms (1)

epcoritamab

EXPERIMENTAL

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

Drug: epcoritamab

Interventions

epcoritamabDRUG

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

epcoritamab

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adrian U Wiestner, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 6, 2024

Study Start

July 18, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be made available by the end of the project/protocol or at the time of associated publication, whichever comes first.
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.

Locations

US(1)