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Can a bispecific antibody wipe out residual leukemia cells in High-Risk CLL?

NCT ID NCT07819214

Disease control Sponsor: University of California, Irvine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether adding epcoritamab can help high-risk chronic lymphocytic leukemia (CLL) patients who are already taking a BTK inhibitor clear remaining cancer cells. The trial enrolls 24 adults with CLL and specific risk factors such as a 17p deletion, TP53 mutation, or complex karyotype. Participants receive epcoritamab with the goal of reaching undetectable measurable residual disease, which may allow them to stop the BTK inhibitor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epcoritamab, an experimental bispecific antibody that helps the immune system attack leukemia cells
What this could lead to
If it works, this approach could give high-risk CLL patients a way to deepen their response and possibly stop treatment with fewer lingering cancer cells.
What could go wrong
This is a small phase 2 trial with 24 participants, so results may not hold in larger groups. Epcoritamab can cause serious immune reactions and infections, and not everyone will respond.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Leukemia, B-Cell

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BTKI Chronic lymphocytic leukemia (CLL) CLL CLL (chronic lymphocytic leukemia)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Chao Family Comprehensive Cancer Center, University of California, Irvine

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

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