CLLPhase 2NCT07819214
Epcoritamab as Consolidation Therapy for High-Risk Pts w/CLL on BTKI
A Phase 2 study testing Epcoritamab in people with CLL and CLL (Chronic Lymphocytic Leukemia), run by University of California, Irvine at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CLL, CLL (Chronic Lymphocytic Leukemia), Chronic Lymphocytic Leukemia (CLL)
- What is being tested?
- Epcoritamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with CLL and at least 1 of the following risk factors:
- ≥1 prior line of therapy before BTKi
- 17p deletion and/or TP53 mutation
- Complex karyotype (≥3 chromosomal abnormalities)
- Treated with a BTKi for ≥ 6 months
- Receiving or able to obtain a commercial supply of BTKi
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, 92868
Catherine C Coombs, MD, 1-877-827-8839, ucstudy@uci.edu
About this study
Official title: 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).
- Being tested
- Epcoritamab
- Keywords
- CLL, Chronic Lymphocytic Leukemia, BTKi, Bruton Tyrosine Kinase Inhibitor, Epcoritamab
- Medical subject headings
- Leukemia, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Interventional Arm
| Study group | Role | What they receive |
|---|---|---|
| Epcoritamab | Experimental | Given IV Receives: Drug: Epcoritamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment
Efficacy will be determined by rate of uMRD at EOT for both Epcoritamab and BTKi discontinuation
Measured: 1 year
Secondary outcomes (1)
Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLLStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Genmab
- Responsible party
- Principal investigator, Catherine Coombs, University of California, Irvine
- Investigators
- Catherine C Coombs, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819214
- Sponsor's protocol ID
- STUDY00000092
- Other IDs
- UCI 24-32
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epcoritamab as Consolidation Therapy for High-risk Patients With Chronic Lymphocytic Leukemia on Bruton Tyrosine Kinase Inhibitor
- ClinicalTrials.gov ID
- NCT07819214
- Acronym / sponsor ID
- STUDY00000092
- Keywords
- CLL, Chronic Lymphocytic Leukemia, BTKi, Bruton Tyrosine Kinase Inhibitor, Epcoritamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Genmab
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epcoritamab | Experimental | Drug: EpcoritamabGiven IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with CLL and at least 1 of the following risk factors:
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabInterventional Arm | Drug | Epcoritamab |
Primary outcome
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 secondary outcome
Number of Participants with Complete Remission (CR) by International Workshop on CLL (iwCLL) criteria
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
Catherine C Coombs, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epcoritamab in people with CLL and CLL (Chronic Lymphocytic Leukemia), run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Undetectable Measurable Residual Disease (uMRD) at End of Treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.