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

NCT ID: NCT06667687

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2031-11-30

Brief 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 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

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291

Participants 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.

Group Type: EXPERIMENTAL

ABBV-291

Intervention Type: DRUG

Intravenous Infusion

Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291

Participants with R/R DLBCL will receive the recommended Phase 1 expansion dose (RP1ED) of ABBV-291, as part of the 74 month study duration.

Group Type: EXPERIMENTAL

ABBV-291

Intervention Type: DRUG

Intravenous Infusion

Expansion: Follicular Lymphoma (FL) ABBV-291

Participants with R/R FL will receive the RP1ED of ABBV-291, as part of the 74 month study duration.

Group Type: EXPERIMENTAL

ABBV-291

Intervention Type: DRUG

Intravenous Infusion

Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose A

Participants with R/R MCL will receive the dose A of ABBV-291, as part of the 74 month study duration.

Group Type: EXPERIMENTAL

ABBV-291

Intervention Type: DRUG

Intravenous Infusion

Optimization: MCL ABBV-291 Dose B

Participants with R/R MCL will receive the dose B of ABBV-291, as part of the 74 month study duration.

Group Type: EXPERIMENTAL

ABBV-291

Intervention Type: DRUG

Intravenous Infusion

Optimization: MCL ABBV-291 Dose C

Participants with R/R MCL will receive the dose C of ABBV-291, as part of the 74 month study duration.

Group Type: EXPERIMENTAL

ABBV-291

Intervention Type: DRUG

Intravenous Infusion

Interventions

ABBV-291

Intravenous Infusion

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Carolina BioOncology Institute /ID# 265259

Huntersville, North Carolina, United States

Site Status: COMPLETED

Willamette Valley Cancer Institute and Research Center /ID# 270945

Eugene, Oregon, United States

Site Status: RECRUITING

Texas Oncology - Central/South Texas /ID# 270946

Austin, Texas, United States

Site Status: RECRUITING

START Mountain Region /ID# 267592

West Valley City, Utah, United States

Site Status: COMPLETED

Virginia Cancer Specialists - Fairfax /ID# 265082

Fairfax, Virginia, United States

Site Status: COMPLETED

St Vincent's Hospital Melbourne /ID# 261664

Fitzroy Melbourne, Victoria, Australia

Site Status: RECRUITING

Sir Charles Gairdner Hospital /ID# 268579

Nedlands, Western Australia, Australia

Site Status: RECRUITING

Hadassah Medical Center-Hebrew University /ID# 261658

Jerusalem, Jerusalem, Israel

Site Status: RECRUITING

Tel Aviv Sourasky Medical Center /ID# 261659

Tel Aviv, Tel Aviv, Israel

Site Status: RECRUITING

Aichi Cancer Center /ID# 267471

Nagoya, Aichi-ken, Japan

Site Status: RECRUITING

National Cancer Center Hospital East /ID# 261775

Kashiwa-shi, Chiba, Japan

Site Status: RECRUITING

The Cancer Institute Hospital Of JFCR /ID# 267470

Koto-ku, Tokyo, Japan

Site Status: RECRUITING

The Christie /ID# 267177

Manchester, , United Kingdom

Site Status: RECRUITING

University Hospitals Plymouth NHS Trust /ID# 267174

Plymouth, , United Kingdom

Site Status: RECRUITING

Countries

United States; Australia; Israel; Japan; United Kingdom

Central Contacts

ABBVIE CALL CENTER

Role: CONTACT

abbvieclinicaltrials@abbvie.com

844-663-3742

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M24-893

Related Info

Other Identifiers

2024-512586-13-00

Identifier Type: OTHER

Identifier Source: secondary_id

M24-893

Identifier Type: -

Identifier Source: org_study_id