Epcoritamab as Consolidation Therapy for High-Risk Pts w/CLL on BTKI

September 8, 2026 updated by: Catherine Coombs, University of California, Irvine

Epcoritamab as Consolidation Therapy for High-risk Patients With Chronic Lymphocytic Leukemia on Bruton Tyrosine Kinase Inhibitor

This is a phase 2, single-arm, open-label clinical trial determining efficacy of Epcoritamab in subjects with Chronic Lymphocytic Leukemia (CLL) on Burton Tyrosine Kinase Inhibitor (BTKi).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Phone Number: 1-877-827-8839
  • Email: ucstudy@uci.edu

Study Contact Backup

  • Name: University of California Irvine Medical

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
        • Contact:
          • Catherine C Coombs, MD
          • Phone Number: 1-877-827-8839
          • Email: ucstudy@uci.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with CLL and at least 1 of the following risk factors:

    1. ≥1 prior line of therapy before BTKi
    2. 17p deletion and/or TP53 mutation
    3. Complex karyotype (≥3 chromosomal abnormalities)
  • Treated with a BTKi for ≥ 6 months
  • Receiving or able to obtain a commercial supply of BTKi
  • Measurable residual disease defined as the presence of CLL cells by conventional flow cytometry
  • ALC ≤10 K/mcL
  • Lymph nodes ≤5 cm in the longest diameter
  • Normal organ function and hematologic parameters
  • ECOG performance status of 0-1

Exclusion Criteria:

  • Active CNS involvement
  • Active immune-mediated cytopenias
  • Current or prior Richter's transformation
  • Second active malignancy requiring treatment (excluding non-melanamatous skin cancers and cancers requiring hormonal therapies alone such as breast/prostate cancer)
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epcoritamab
Given IV
Drug: Epcoritamab
Interventional Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment
Time Frame: 1 year
Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria
Time Frame: 1 year
CR by iwCLL criteria is defined as meeting all parameters which include lymph nodes, liver and/or spleen size, constitutional systems, circulating lymphocyte count, platelet count, hemoglobin, and marrow.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Genmab

Investigators

  • Principal Investigator: Catherine C Coombs, MD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2032

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 8, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000092
  • UCI 24-32 (Other Identifier: UCI CFCCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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