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New pill takes aim at Hard-to-Treat blood cancers

NCT ID NCT05753501

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Updated 9 times

Summary

This early study tests a new drug called ABBV-101 in people with several types of non-Hodgkin lymphoma that have come back or not responded to other treatments. The drug is a pill that targets a protein (BTK) involved in cancer growth. The main goals are to find a safe dose and see if it can shrink tumors. About 135 adults will take part worldwide.

What this could mean

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

Active substance
ABBV-101 (a BTK degrader drug taken by mouth)
What this could lead to
If this works, it could offer a new treatment option for people with certain blood cancers that have not responded to other therapies.
What could go wrong
This is a very early (first-in-human) study, so safety and effectiveness are not yet known. It may not work or could have unexpected 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

135 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Mar 2031

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: * For Dose Escalation (Part 1) only (including backfill): Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have a documented diagnosis for one of the following third line or later B-cell malignancies, from one of the following world health organization (WHO)-defined histologies (Swerdlow et al 2016): * Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) 1. For Dose Escalation (Part 1) backfill only - Bruton's tyrosine kinase inhibitor (BTKi)/Bruton's tyrosine kinase degrader (BTKd)-naïve CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received at least one prior systemic therapy that cannot be a BTK inhibitor or degrader, and, with the exception of BTK pathway agents, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment. 2. For Dose Escalation (Part 1) backfill only - BTKi/BCL-2i combination regimen-exposed 2L CLL/SLL. Participants with a documented diagnosis of CLL/SLL who have received one prior systemic therapy with a BTKi and BCL-2i combination regimen, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), and have measurable disease requiring treatment. * Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell \[GCB\] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS. * Mantle cell lymphoma (MCL) * Follicular lymphoma \[FL\] (grades 1-3b) * Marginal zone lymphoma \[MZL\] (splenic, extranodal, and nodal) * Waldenström macroglobulinemia (WM) * Transformed indolent non-Hodgkin's lymphoma (iNHL) * For Dose Expansion (Part 2a) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL in their first-line or later treatment. * For Dose Expansion (Part 2a) DLBCL only: Participants have received at least two prior systemic therapies, have no available therapies known to provide clinical benefit (e.g., standard chemotherapy or HCT), have measurable disease requiring treatment, and have documented diagnosis of CAR-T/HCT R/R or ineligible non-GCB DLBCL who are in their third line or later treatment with histology based on criteria established by the WHO. * For Dose Exploration of ABBV-101 combination with venetoclax (Part 2b) CLL/SLL only: Participants with a documented diagnosis of CLL/SLL in their first-line or later treatment: In safety lead-in for each dose level, participants must have received at least one prior systemic therapy. * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2. For EU only: Participant has an ECOG PS of 0 or 1. * Participant has a life expectancy \>= 12 weeks. * Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed. * Adequate hematologic, renal, and hepatic function per the protocol. Exclusion Criteria: * Previously treated with a Bruton's tyrosine kinase (BTK) degrader. * Known active central nervous system (CNS) disease, or primary CNS lymphoma. Participants with prior CNS disease that have been effectively treated may be eligible. * Uncontrolled active systemic infection requiring systemic treatment that is ongoing or was completed \<= 14 days before the first dose of study drug, or active cytomegalovirus infection.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma diffuse large B-cell lymphoma activated B-cell type follicular lymphoma hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm indolent B-cell non-Hodgkin lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma Recurrence Waldenstrom macroglobulinemia

As listed by the trial registrant

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

Hematologic cancer

Contacts and locations

Locations

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 253530

    Turin, Piedmont, 10126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 253532

    Milan, Milano, 20162, Italy

  • Addenbrookes Hospital /ID# 256242

    Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

  • Arizona Oncology - Tucson - Wilmot Road /ID# 252351

    Tucson, Arizona, 85711, United States

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII /ID# 260317

    Bergamo, 24127, Italy

  • Beth Israel Deaconess Medical Center /ID# 249302

    Boston, Massachusetts, 02215-5400, United States

  • CHRU Lille - Hopital Claude Huriez /ID# 253665

    Lille, Nord, 59037, France

  • CHU Montpellier - Hopital Saint Eloi /ID# 253666

    Montpellier, Herault, 34295, France

  • CHUM Notre-Dame Hospital /ID# 253428

    Montreal, Quebec, H2L 4M1, Canada

  • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 256248

    Nantes, Pays de la Loire Region, 44000, France

  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 257431

    Berlin, 12203, Germany

  • Hadassah Medical Center-Hebrew University /ID# 251123

    Jerusalem, Jerusalem, 91120, Israel

  • Hopital Saint-Louis /ID# 253663

    Paris, 75010, France

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 253654

    Madrid, 28040, Spain

  • Hospital Universitario HM Sanchinarro /ID# 253655

    Madrid, 28050, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 260196

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal /ID# 260450

    Madrid, 28034, Spain

  • Hospital Universitario Vall de Hebron /ID# 260447

    Barcelona, 08035, Spain

  • Hospital Universitario de Salamanca /ID# 253656

    Salamanca, 37711, Spain

  • IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 255172

    Bologna, 40138, Italy

  • IRCCS Ospedale San Raffaele /ID# 253531

    Milan, Milano, 20132, Italy

  • Institut Bergonie /ID# 253664

    Bordeaux, Gironde, 33000, France

  • Institut Gustave Roussy /ID# 253662

    Villejuif, Val-de-Marne, 94805, France

  • Kings College Hospital NHS Foundation Trust /ID# 253670

    London, Greater London, SE5 9RS, United Kingdom

  • Kyoto University Hospital /ID# 261837

    Kyoto, Kyoto, 606-8507, Japan

  • Leicester Royal Infirmary /ID# 255171

    Leicester, England, LE1 5WW, United Kingdom

  • MD Anderson Cancer Center /ID# 249293

    Houston, Texas, 77030, United States

  • National Cancer Center Hospital /ID# 250680

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East /ID# 250684

    Kashiwa-shi, Chiba, 277-8577, Japan

  • New York Oncology Hematology - Albany Cancer Center /ID# 252240

    Albany, New York, 12206-5013, United States

  • Northwell Health - Monter Cancer Center /ID# 250422

    Lake Success, New York, 11042, United States

  • Northwestern University Feinberg School of Medicine /ID# 249347

    Chicago, Illinois, 60611-2927, United States

  • Oncology Assoc. of Oregon PC - WVCI and Research Ctr - Springfield /ID# 249309

    Eugene, Oregon, 97401-6036, United States

  • Rocky Mountain Cancer Centers - Lone Tree /ID# 252237

    Lone Tree, Colorado, 80124, United States

  • Rutgers Cancer Institute of New Jersey /ID# 249323

    New Brunswick, New Jersey, 08901, United States

  • Stanford University - Palo Alto /ID# 249683

    Palo Alto, California, 94304, United States

  • Tel Aviv Sourasky Medical Center /ID# 259608

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Cancer Institute Hospital Of JFCR /ID# 260375

    Koto-ku, Tokyo, 135-8550, Japan

  • The Chaim Sheba Medical Center /ID# 251122

    Ramat Gan, Tel Aviv, 5265601, Israel

  • UC Health - Cincinnati /ID# 249299

    Cincinnati, Ohio, 45267-2800, United States

  • UC Irvine Medical Center /ID# 263020

    Orange, California, 92868-3201, United States

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 264566

    Hamburg, 20246, Germany

  • Universitaetsklinikum Ulm /ID# 253742

    Ulm, Baden-Wurttemberg, 89081, Germany

  • Universitaetsklinikum Wuerzburg /ID# 254636

    Würzburg, Bavaria, 97080, Germany

  • Universitaetsklinikum des Saarlandes /ID# 257435

    Homburg, Saarland, 66424, Germany

  • Universitaetsmedizin Rostock /ID# 259657

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

  • University College London Hospital /ID# 260202

    London, Greater London, NW1 2BU, United Kingdom

  • University Health Network_Princess Margaret Cancer Centre /ID# 253483

    Toronto, Ontario, M5G 2M9, Canada

  • University of Pennsylvania /ID# 250341

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester Medical Center /ID# 249324

    Rochester, New York, 14642-0001, United States

  • Yitzhak Shamir Medical Center /ID# 254566

    Ẕerifin, Central District, 70300, Israel

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