ClinicalTrials.gg
Not yet recruitingNCT07819214Updated Nov 9, 2026

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

A Phase 2 interventional study of Epcoritamab in CLL, CLL (Chronic Lymphocytic Leukemia) and Chronic Lymphocytic Leukemia (CLL), sponsored by University of California, Irvine. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Primary conditionLeukemia, Lymphocytic, Chronic, B-CellRegistry: Leukemia, B-CellReclassifiedWhy we changed it
Registry
Leukemia, B-Cell — the first condition term the registry derived for this study.
ClinicalTrials.gg
Leukemia, Lymphocytic, Chronic, B-Cell
Why
  1. The study's listed conditions name Leukemia, Lymphocytic, Chronic, B-Cell, a narrower term within Leukemia, B-Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, Irvine · Phase 2, Interventional, and Treatment

Updated Nov 9, 2026Start date movedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • CLL
  • CLL (Chronic Lymphocytic Leukemia)
  • Chronic Lymphocytic Leukemia (CLL)
  • BTKi

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Keywords

  • CLL
  • Chronic Lymphocytic Leukemia
  • BTKi
  • Bruton Tyrosine Kinase Inhibitor
  • Epcoritamab
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell Reclassified

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's planned enrollment of 24 is below the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Compared within Leukemia, Lymphocytic, Chronic, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Leukemia, B-Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

    1. ≥1 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
  • performance status of 0-1

Exclusion criteria

Exclusion Criteria:

  • Active CNS involvement
  • Active immune-mediated cytopenias
  • Current or prior Richter's transformation
  • Second active requiring treatment (excluding non-melanamatous skin cancers and cancers requiring hormonal therapies alone such as breast/prostate cancer)
  • Pregnant or breastfeeding
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Epcoritamab

    Given IV

    Drug: Epcoritamab

Interventions

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Oct 2028, 22 months later.

Of 208 non-industry phase 2 interventional studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 119. This study's planned 22 months is below that.

Counting every sponsor, half of 249 studies reached it within 73 months; a quarter within 41 and three quarters within 114.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 9, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 14, 2026
StartEst.
Dec 2026was Oct 2026
Primary completionEst.
Oct 2028
CompletionEst.
Oct 2032
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Oct 2026→Dec 2026
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Start date Oct 2026→Dec 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07819214
Collaborators
Genmab
Responsible party
Catherine Coombs (Associate Clinical Professor, University of California, Irvine) — Principal investigator
First posted
Sep 14, 2026
Start date
Dec 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2032 (estimated)
Last update
Nov 9, 2026

Study contacts

Chao Family Comprehensive Cancer Center University of California, Irvine
Contact
ucstudy@uci.edu
1-877-827-8839
University of California Irvine Medical
Contact
Catherine C Coombs, MD
principal investigator · Chao Family Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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