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Non-Hodgkin's LymphomaPhase 1NCT06667687

Study to Evaluate Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-291 Moves Through the Body in Adult Participants With Non-Hodgkin's Lymphoma

A Phase 1 study testing ABBV-291 in people with Non-Hodgkin's Lymphoma, run by AbbVie at 14 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
ABBV-291
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
14 sitesin 5 countries
Study dates
16 Jan 2025to Nov 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 5 countries.

14 sites in 5 countries

United States5 sites

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

    Austin, Texas, 78705

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

    Eugene, Oregon, 97401

  • Virginia Cancer Specialists - Fairfax /ID# 265082

    Fairfax, Virginia, 22031

  • Carolina BioOncology Institute /ID# 265259

    Huntersville, North Carolina, 28078

  • START Mountain Region /ID# 267592

    West Valley City, Utah, 84119-3602

Other trials in United States

Japan3 sites

  • National Cancer Center Hospital East /ID# 261775

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital Of Japanese Foundation for Cancer Research /ID# 267470

    Koto-ku, Tokyo, 135-8550

  • Aichi Cancer Center /ID# 267471

    Nagoya, Aichi-ken, 464-8681

Other trials in Japan

Australia2 sites

  • St Vincent's Hospital Melbourne /ID# 261664

    Fitzroy Melbourne, Victoria, 3065

  • Sir Charles Gairdner Hospital /ID# 268579

    Nedlands, Western Australia, 6009

Other trials in Australia

Israel2 sites

  • Hadassah Medical Center-Hebrew University /ID# 261658

    Jerusalem, Jerusalem, 91120

  • Tel Aviv Sourasky Medical Center /ID# 261659

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

United Kingdom2 sites

  • The Christie /ID# 267177

    Manchester, M20 4BX

  • University Hospitals Plymouth NHS Trust /ID# 267174

    Plymouth, PL6 5FP

Other trials in United Kingdom

About this study

Official title: A Phase 1 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV 291 in Non-Hodgkin's Lymphoma

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or refractory (R/R) NHL, including but not limited to diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and follicular lymphoma (FL). Adverse events will be assessed.

ABBV-291 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-291 and a dose expansion/optimization phase to determine the change in disease activity in participants with R/R NHL. Approximately 165 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide

Read more

In the dose escalation phase of the study participants will receive escalating Intravenously (IV) infused doses of ABBV-291, until the MAD/MTD is determined. In the dose expansion/optimization phase of the study participants receive IV infused ABBV-291, as part of the approximately 74 month study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

Being tested
ABBV-291
Keywords
Non-Hodgkin's Lymphomas, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstroms Macrogloulinemia, Germinal Center B-cell, Activated B-Cell, NHL, DLBCL, MCL, FL, MZL, WM, GCB, ABC, Cancer, ABBV-291
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-291Drug

    Intravenous Infusion

Study groups in NCT06667687
Study groupRoleWhat they receive
Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291ExperimentalParticipants with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), except chronic lymphocytic leukemia (CLL), will receive escalating doses of ABBV-291, as part of the 74 month study duration.
Receives: Drug: ABBV-291
Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291ExperimentalParticipants with R/R DLBCL will receive the recommended Phase 1 expansion dose (RP1ED) of ABBV-291, as part of the 74 month study duration.
Receives: Drug: ABBV-291
Expansion: Follicular Lymphoma (FL) ABBV-291ExperimentalParticipants with R/R FL will receive the RP1ED of ABBV-291, as part of the 74 month study duration.
Receives: Drug: ABBV-291
Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose AExperimentalParticipants with R/R MCL will receive the dose A of ABBV-291, as part of the 74 month study duration.
Receives: Drug: ABBV-291
Optimization: MCL ABBV-291 Dose BExperimentalParticipants with R/R MCL will receive the dose B of ABBV-291, as part of the 74 month study duration.
Receives: Drug: ABBV-291
Optimization: MCL ABBV-291 Dose CExperimentalParticipants with R/R MCL will receive the dose C of ABBV-291, as part of the 74 month study duration.
Receives: Drug: ABBV-291

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with Adverse Events (AE)s

    An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 74 Months

  2. Percentage of Participants with Dose Limiting Toxicities (DLT)s

    DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

    Measured: Up to 74 Months

  3. Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, and Hematology)

    Percentage of participants with clinically significant laboratory values (chemistry, and hematology).

    Measured: Up to 74 Months

  4. Percentage of Participants with Clinically Significant Vital Sign Measurements

    Vital sign are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature.

    Measured: Up to 74 Months

  5. Percentage of Participants with Clinically Significant Electrocardiogram (ECG) Findings

    Percentage of participants with clinically significant ECG findings.

    Measured: Up to 74 Months

  6. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with a confirmed best overall response (BOR) of partial response (PR) or better per disease-specific response criteria (e.g., Lugano classification).

    Measured: Up to 74 Months

Secondary outcomes (7)

  1. Duration of Response (DOR) as Assessed by Investigator

    DOR is defined for participants achieving a confirmed PR or better as the time from the initial response of PR (or better) per investigator review according to disease-specific response criteria to disease progression or death of any cause, whichever occurs earlier.

    Measured: Up to 74 Months

  2. Progression-Free Survival (PFS) as Assessed by Investigator

    PFS is defined as time from first study treatment to a documented disease progression according to disease-specific response criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.

    Measured: Up to 74 Months

  3. Time to response (TTR)

    TTR is defined as time from first study treatment to the initial response of PR (or better) per investigator review according to disease-specific response criteria.

    Measured: Up to 74 Months

  4. Area Under the Curve (AUC) of ABBV-291

    AUC is defined as the area under the plasma/serum concentration-time curve of ABBV-291.

    Measured: Up to 12 Months

  5. Maximum Observed Plasma/Serum Concentration (Cmax) of ABBV-291

    Cmax is defined as maximum observed plasma/serum concentration of ABBV-291.

    Measured: Up to 12 Months

  6. Time to Cmax (Tmax) of ABBV-291

    Tmax is defined as time to Cmax of ABBV-291.

    Measured: Up to 12 Months

  7. Half-Life (t1/2) of ABBV-291

    t1/2 is defined as the half-life of ABBV-291.

    Measured: Up to 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2024
  2. Study start16 Jan 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionNov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06667687
Sponsor's protocol ID
M24-893
Other IDs
2024-512586-13-00
Status last verified
Sep 2026
First submitted
30 Oct 2024
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-291 in people with Non-Hodgkin's Lymphoma, run by AbbVie at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, Japan, Australia, Israel, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Adverse Events (AE)s (time frame: Up to 74 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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