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New pill targets Hard-to-Treat blood cancers in early human trial

NCT ID NCT05618028

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage trial tests an experimental oral drug called ABBV-525 in people with B-cell blood cancers like lymphoma and leukemia. The study aims to find a safe dose and check for side effects. About 78 adults will take the drug in different dose groups over up to 64 months.

What this could mean

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

Active substance
ABBV-525 (MALT1 inhibitor)
What this could lead to
If this drug works, it could offer a new treatment option for people with certain blood cancers that haven't responded to other therapies.
What could go wrong
This is a very early (Phase 1) trial with only 78 participants, so it's mainly checking safety and dosing. The drug may not work well or could have side effects.

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

78 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jul 2029

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: * Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol. * Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL). * Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment. * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. * Participant has a life expectancy \>= 12 weeks. * Adequate hematological and hepatic function as defined in the protocol. * Must have archival or freshly collected tumor tissue for correlative studies before study enrollment. * Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible. * Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible. Exclusion Criteria: * Known active CNS disease, or primary CNS lymphoma. * Known bleeding disorders. * Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment. * Uncontrolled active systemic infection, or active cytomegalovirus infection. * Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol. * Known history of human immunodeficiency virus (HIV). * Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm diffuse large B-cell lymphoma neoplasm non-Hodgkin lymphoma

As listed by the trial registrant

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

B cell malignancies Chronic lymphocytic leukemia Diffuse large B cell lymphoma Non-Hodgkin's lymphoma

Contacts and locations

Locations

  • Asan Medical Center /ID# 266341

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Atrium Health Levine Cancer Institute /ID# 246363

    Charlotte, North Carolina, 28204, United States

  • Bankstown-Lidcombe Hospital /ID# 260191

    Bankstown, New South Wales, 2200, Australia

  • CHRU Lille - Hopital Claude Huriez /ID# 252054

    Lille, Nord, 59037, France

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062

    Berlin, 13353, Germany

  • China Medical University Hospital /ID# 266414

    Taichung, 40447, Taiwan

  • Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113

    Fort Wayne, Indiana, 46804, United States

  • Hadassah Medical Center-Hebrew University /ID# 251441

    Jerusalem, Jerusalem, 91120, Israel

  • Hospital Clinic de Barcelona /ID# 246543

    Barcelona, 08036, Spain

  • Hospital Universitario 12 de Octubre /ID# 246538

    Madrid, 28041, Spain

  • Hospital Universitario Ramon y Cajal /ID# 246540

    Madrid, 28034, Spain

  • Hospital Universitario Vall de Hebron /ID# 245475

    Barcelona, 08035, Spain

  • IUCT Oncopole /ID# 259409

    Toulouse, Occitanie, 31059, France

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872

    Indianapolis, Indiana, 46202-5116, United States

  • Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Leeds Teaching Hospitals NHS Trust /ID# 245470

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459

    New York, New York, 10065-6007, United States

  • Monash Health - Monash Medical Centre /ID# 246366

    Clayton, Victoria, 3168, Australia

  • Mount Sinai Medical Center-Miami Beach /ID# 248251

    Miami Beach, Florida, 33140-2948, United States

  • National Taiwan University Hospital /ID# 266343

    Taipei, 100, Taiwan

  • Northwest Medical Specialties - Tacoma /ID# 260376

    Tacoma, Washington, 98405, United States

  • Orange Health Service /ID# 260473

    Orange, New South Wales, 2800, Australia

  • Rabin Medical Center. /ID# 257665

    Petah Tikva, Central District, 4941492, Israel

  • START Midwest /ID# 252359

    Grand Rapids, Michigan, 49546, United States

  • Samsung Medical Center /ID# 266415

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 266340

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Shamir Medical Center /ID# 257711

    Beer Ya'akov, Central District, 70300, Israel

  • The Alfred Hospital /ID# 248592

    Melbourne, Victoria, 3004, Australia

  • The Chaim Sheba Medical Center /ID# 251442

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Christie Hospital /ID# 250325

    Manchester, M20 4BX, United Kingdom

  • The Royal Marsden NHS Foundation Trust /ID# 250324

    London, SW3 6JJ, United Kingdom

  • Tulane Cancer Center Clinic /ID# 249586

    New Orleans, Louisiana, 70112, United States

  • UZ Gent /ID# 246462

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Universitair Ziekenhuis Leuven /ID# 246461

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University Of Cincinnati Medical Center /ID# 262288

    Cincinnati, Ohio, 45219, United States

  • University of California Los Angeles Medical Center /ID# 246357

    Los Angeles, California, 90095, United States

  • University of Texas MD Anderson Cancer Center /ID# 245463

    Houston, Texas, 77030, United States

  • University of Utah Health Hospital /ID# 259924

    Salt Lake City, Utah, 84132, United States

  • Yale University School of Medicine /ID# 259081

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.