New hope for Hard-to-Treat lymphoma? early trial of ABBV-291 begins
NCT ID NCT06667687
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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21 people
The number who actually took part.
- Started
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Jan 2025
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Aichi Cancer Center /ID# 267471
Nagoya, Aichi-ken, 464-8681, Japan
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Carolina BioOncology Institute /ID# 265259
Huntersville, North Carolina, 28078, United States
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Hadassah Medical Center-Hebrew University /ID# 261658
Jerusalem, Jerusalem, 91120, Israel
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National Cancer Center Hospital East /ID# 261775
Kashiwa-shi, Chiba, 277-8577, Japan
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START Mountain Region /ID# 267592
West Valley City, Utah, 84119-3602, United States
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Sir Charles Gairdner Hospital /ID# 268579
Nedlands, Western Australia, 6009, Australia
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St Vincent's Hospital Melbourne /ID# 261664
Fitzroy Melbourne, Victoria, 3065, Australia
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Tel Aviv Sourasky Medical Center /ID# 261659
Tel Aviv, Tel Aviv, 6423906, Israel
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Texas Oncology - Central/South Texas /ID# 270946
Austin, Texas, 78705, United States
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The Cancer Institute Hospital Of JFCR /ID# 267470
Koto-ku, Tokyo, 135-8550, Japan
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The Christie /ID# 267177
Manchester, M20 4BX, United Kingdom
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University Hospitals Plymouth NHS Trust /ID# 267174
Plymouth, PL6 5FP, United Kingdom
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Virginia Cancer Specialists - Fairfax /ID# 265082
Fairfax, Virginia, 22031, United States
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Willamette Valley Cancer Institute and Research Center /ID# 270945
Eugene, Oregon, 97401, United States
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