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New hope for Hard-to-Treat lymphoma? early trial of ABBV-291 begins

NCT ID NCT06667687

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called ABBV-291 in adults with Non-Hodgkin's lymphoma that has come back or stopped responding to treatment. The study will first find the safest dose, then check if the drug can shrink tumors. About 165 participants 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-291 (given as an intravenous infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with Non-Hodgkin's lymphoma that has not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or could have serious side effects. It is also a small study, so results may not apply to all patients.

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

21 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Apr 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: * For dose escalation (Part 1) only: Participants must have documented diagnosis of B-cell malignancies including (but not limited to) the following, with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment: * Mantle cell lymphoma (MCL); * Marginal zone lymphoma (MZL); * Waldenstrom macroglobulinemia (WM); * Diffuse large b-cell lymphoma (DLBCL) (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL \[leg type\], Epstein-Barr virus-positive (EBV+) DLBCL \[not otherwise specified\], DLBCL associated with chronic inflammation, human herpesvirus 8-positive \[HHV8+\] DLBCL \[not otherwise specified\], B cell lymphoma \[unclassifiable\] with features intermediate between DLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma \[not otherwise specified\], high-grade B-cell lymphoma \[with MYC (avian myelocytomatosis viral oncogene homolog) and BCL2 and/or BCL6 rearrangements\], DLBCL arising from follicular lymphoma \[FL\] \[transformed FL\]); * FL Grades 1 to 3B; * For dose expansion (Part 2) only: Participants must have documented diagnosis of one of the following B-cell malignancies, with histology based on criteria established by the WHO, and measurable disease requiring treatment: * Part 2a only: DLBCL (including: germinal center B-cell type, activated B-cell type, primary cutaneous DLBCL \[leg type\], EBV+ DLBCL \[not otherwise specified\], DLBCL associated with chronic inflammation, HHV8+ DLBCL \[not otherwise specified\], B-cell lymphoma \[unclassifiable\] with features intermediate between DLBCL and classical Hodgkin lymphoma, high-grade B-cell lymphoma \[not otherwise specified\], high-grade B-cell lymphoma \[with MYC and BCL2 and/or BCL6 rearrangements\], DLBCL arising from FL \[transformed FL\]); * Part 2b only: FL Grades 1 to 3B; * Part 2c only: Mantle cell lymphoma; * For all participants (Parts 1 and 2): * Must be considered relapsed or refractory to, or intolerant of, at least 2 or more prior lines of therapy known to provide a clinical benefit for their condition, and for whom there is no appropriate locally available therapy known to provide clinical benefit (e.g., standard chemotherapy or autologous stem cell transplantation \[ASCT\]). * Indolent non-Hodkin's lymphoma (NHL) participants must meet relevant disease specific requirements for treatment (e.g., National Comprehensive Cancer Network \[NCCN\], Groupe d'Etude des Lymphomes Folliculaires \[GELF\]). * History of allogeneic stem cell transplantation must be stable off of immunosuppression for at least 3 months. * For participants enrolled in backfill cohorts or at dose levels previously cleared, subjects must provide consent to an on-treatment fresh tumor biopsy from the same tumor lesion as the baseline tumor tissue. This requirement may be waived at the discretion of the contract research organization (CRO) Medical Monitor if collecting a biopsy would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a subject's ability to participate in the study. * Previously treated with a CD79b-targeting therapy (e.g., CD79b monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD79b-targeting therapy must be collected. Tumor biopsy requirements may be modified by Sponsor during the study. This requirement may be waived at the discretion of the contract research organization (CRO) Medical Monitor if collecting a biopsy would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a subject's ability to participate in the study. * CD79b expression status will be assessed in all participants. * Have an eastern cooperative oncology group (ECOG) Performance Status of 0 or 1. * Laboratory values meeting the criteria in the protocol within the screening period prior to the first dose of study drug (if multiple samples are drawn within the screening period, the sample/result immediately prior to Cycle 1 Day 1 is applicable). * Availability of representative baseline tumor tissue (most recent archived tumor tissue or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the CRO Medical Monitor if collecting a biopsy at screening would place the participant at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator or could hinder a participant's ability to participate in the study. Exclusion Criteria: * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis. * Treatment with any of the following: * Anticancer therapy including chemotherapy, radiotherapy, small molecule, investigational, and biologic agents within 14 days (or at least 5 half-lives, whichever is shorter), prior to the first dose of the study treatment; * CD79b-directed agents (e.g., CD79b monoclonal antibody therapy) within 4 weeks (or at least 5 half-lives, whichever is shorter) prior to the first dose of study treatment. * Prior treatment with an antibody drug conjugate that consists of a topoisomerase I inhibitor.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Aichi Cancer Center /ID# 267471

    Nagoya, Aichi-ken, 464-8681, Japan

  • Carolina BioOncology Institute /ID# 265259

    Huntersville, North Carolina, 28078, United States

  • Hadassah Medical Center-Hebrew University /ID# 261658

    Jerusalem, Jerusalem, 91120, Israel

  • National Cancer Center Hospital East /ID# 261775

    Kashiwa-shi, Chiba, 277-8577, Japan

  • START Mountain Region /ID# 267592

    West Valley City, Utah, 84119-3602, United States

  • Sir Charles Gairdner Hospital /ID# 268579

    Nedlands, Western Australia, 6009, Australia

  • St Vincent's Hospital Melbourne /ID# 261664

    Fitzroy Melbourne, Victoria, 3065, Australia

  • Tel Aviv Sourasky Medical Center /ID# 261659

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Texas Oncology - Central/South Texas /ID# 270946

    Austin, Texas, 78705, United States

  • The Cancer Institute Hospital Of JFCR /ID# 267470

    Koto-ku, Tokyo, 135-8550, Japan

  • The Christie /ID# 267177

    Manchester, M20 4BX, United Kingdom

  • University Hospitals Plymouth NHS Trust /ID# 267174

    Plymouth, PL6 5FP, United Kingdom

  • Virginia Cancer Specialists - Fairfax /ID# 265082

    Fairfax, Virginia, 22031, United States

  • Willamette Valley Cancer Institute and Research Center /ID# 270945

    Eugene, Oregon, 97401, United States

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