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New hope for tough leukemia? early trial of ABBV-453 begins

NCT ID NCT06291220

Disease control Sponsor: AbbVie 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This early-phase study tests an experimental drug called ABBV-453, given with another cancer drug (obinutuzumab), in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or stopped responding to other treatments. About 60 participants will receive the drugs and be monitored for side effects, drug levels in the blood, and any changes in their disease. The main goal is to find a safe dose and see how the body handles the drug.

What this could mean

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

Active substance
ABBV-453 (an investigational drug) combined with obinutuzumab (a cancer antibody)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat CLL or SLL.
What could go wrong
This is a very early Phase 1 trial with only 4 participants so far, focused on safety and dosing. It may not lead to an effective treatment, and side effects are unknown.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior systemic therapies and have no available (or established) therapies known to provide clinical benefit and to which the participant would consent to receiving. * Laboratory values meeting those listed in the protocol. Exclusion Criteria: * QT interval corrected for heart rate (QTc) using Fridericia's correction of \> 470 msec (females) or \> 450 msec (males), Grade 3 arrythmia, and/or other clinically significant cardiac abnormalities. * Known to be B-cell leukemia/lymphoma 2 inhibitor (BCL-2i) refractory or has received a BCL-2i-containing regimen within (6 months) of starting study drug (e.g., venetoclax, lisaftoclax, BGV-11417). * Has active human immunodeficiency virus (HIV) infection. HIV testing is not required unless required locally. * Recent history (within 6 months) of: * Congestive heart failure (defined as New York Heart Association, Class 2 or higher). * Ischemic cardiovascular event. * Cardiac arrhythmia requiring pharmacological or surgical intervention. * Pericardial effusion. * Pericarditis. * Consumes known moderate or strong inhibitors of cytochrome P450 3A isoform subfamily (CYP3A) within 14 day or 5 half-lives of the drug (whichever is shorter) before the first dose of ABBV-453.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia Small lymphocytic lymphoma

Contacts and locations

Locations

  • Atrium Health Levine Cancer Institute /ID# 265136

    Charlotte, North Carolina, 28204, United States

  • Austin Health /ID# 256776

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 263062

    Perugia, 06156, Italy

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 263433

    Berlin, 12203, Germany

  • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 267158

    Irvine, California, 92618, United States

  • City of Hope /ID# 253904

    Duarte, California, 91010, United States

  • Duplicate_Duke Cancer Center /ID# 258707

    Durham, North Carolina, 27710-3000, United States

  • Gold coast University Hospital /ID# 255785

    Southport, Queensland, 4215, Australia

  • Hadassah Medical Center-Hebrew University /ID# 254721

    Jerusalem, Jerusalem, 91120, Israel

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 263065

    Bologna, 40138, Italy

  • IRCCS Ospedale San Raffaele /ID# 263064

    Milan, Milano, 20132, Italy

  • Intermountain Health St Vincent Regional Hospital - Cancer Centers of Montana /ID# 264622

    Billings, Montana, 59102, United States

  • MD Anderson Cancer Center /ID# 253713

    Houston, Texas, 77030, United States

  • Royal Perth Hospital /ID# 256464

    Perth, Western Australia, 6000, Australia

  • Royal Prince Alfred Hospital /ID# 263129

    Sydney, New South Wales, 2050, Australia

  • The Chaim Sheba Medical Center /ID# 254383

    Ramat Gan, Tel Aviv, 5265601, Israel

  • Universitaetsklinikum Halle (Saale) /ID# 263299

    Halle, Saxony-Anhalt, 06120, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 263730

    Hamburg, 20246, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel /ID# 263150

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Ulm /ID# 263148

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Yitzhak Shamir Medical Center /ID# 257626

    Ẕerifin, Central District, 70300, Israel

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