ABBV-291 for Non-Hodgkin's Lymphoma

Recruiting at 12 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Chemotherapy, Radiotherapy, Biologics, others

Disqualifiers: Interstitial lung disease, Pneumonitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of ABBV-291, a new drug for treating non-Hodgkin's lymphoma (NHL), a cancer of the white blood cells. Participants will receive the drug through an IV in various doses to determine the safest and most effective amount. The trial targets adults whose NHL hasn't responded to other treatments, including types like diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). It suits those who have had at least two unsuccessful treatment attempts. Regular visits to a hospital or clinic will monitor the treatment's effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you stop taking any anticancer therapy, including chemotherapy, radiotherapy, small molecule, investigational, and biologic agents, at least 14 days before starting the study treatment. If you are on CD79b-directed agents, you must stop them at least 4 weeks before the study treatment.

Is there any evidence suggesting that ABBV-291 is likely to be safe for humans?

Research has shown that ABBV-291 is being tested for safety in treating Non-Hodgkin's Lymphoma (NHL). In early human trials, ABBV-291 demonstrated strong anti-cancer effects, outperforming similar treatments. These studies aim to understand patient tolerance, potential side effects, and the drug's movement through the body.

Currently, ABBV-291 is in the early testing phase, and researchers are still assessing its safety. This stage is crucial for observing how the body reacts to different doses. Although detailed safety information is not yet available, these studies are designed to identify any serious side effects and determine the safest dose for future research. Participants will receive close monitoring to ensure any side effects are promptly identified and managed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for non-Hodgkin's lymphoma, which often involve chemotherapy and monoclonal antibodies, ABBV-291 works by targeting specific proteins on cancer cells, potentially leading to more precise and effective treatment. Researchers are excited about ABBV-291 because it offers a novel approach that might overcome resistance seen in some patients with relapsed or refractory lymphoma. Additionally, its ability to be tailored in various doses for different types of lymphoma, such as follicular, mantle cell, and diffuse large B-cell lymphoma, allows for optimized treatment strategies that could improve patient outcomes.

What evidence suggests that ABBV-291 might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that ABBV-291 holds strong potential for treating non-Hodgkin's lymphoma (NHL) based on early studies. This trial will examine ABBV-291's effects across different treatment arms. Participants with follicular lymphoma (FL) will receive the recommended Phase 1 expansion dose, and those with diffuse large B-cell lymphoma (DLBCL) will also receive this dose. For mantle cell lymphoma (MCL), participants will be assigned one of three different doses (Dose A, B, or C) of ABBV-291. Additionally, an escalation arm exists for various types of relapsed/refractory NHL, excluding chronic lymphocytic leukemia (CLL), where participants will receive escalating doses of ABBV-291. This drug targets a protein called CD79b, found on certain cancer cells, and has shown better results compared to similar treatments. These findings suggest that ABBV-291 could benefit patients whose cancer has returned or not responded to other treatments. While more research is needed, the initial results are encouraging for those considering joining clinical trials. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with relapsed or refractory Non-Hodgkin's Lymphoma, including types like DLBCL, MCL, and FL. Participants must be willing to undergo frequent medical assessments and blood tests at an approved institution.

Inclusion Criteria

I had a stem cell transplant and have not taken immunosuppressants for 3 months.

Laboratory values meeting the criteria in the protocol within the screening period prior to the first dose of study drug

I have a tumor sample available for testing.

Exclusion Criteria

I have had lung inflammation or disease that needed steroid treatment.

I haven't had cancer treatment recently.

I have been treated with a specific drug that targets cancer cells.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating IV infused doses of ABBV-291 to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD)

Varies

Regular visits at an approved institution

Dose Expansion/Optimization

Participants receive IV infused ABBV-291 to determine the change in disease activity

Up to 74 months

Regular visits at an approved institution

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-291

Trial Overview The trial is testing ABBV-291, a new drug for NHL. It includes two phases: first determining the maximum safe dose (MAD/MTD) through escalating doses; then assessing changes in disease activity at optimized doses over approximately 74 months.

How Is the Trial Designed?

Group I: Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose A Experimental Treatment 1 Intervention

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

Group II: Optimization: MCL ABBV-291 Dose C Experimental Treatment 1 Intervention

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

Group III: Optimization: MCL ABBV-291 Dose B Experimental Treatment 1 Intervention

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

Group IV: Expansion: Follicular Lymphoma (FL) ABBV-291 Experimental Treatment 1 Intervention

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

Group V: Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291 Experimental Treatment 1 Intervention

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 VI: Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.TPS7093

A phase 1 first-in-human study evaluating safety, ... We describe a first-in-human study evaluating the safety, pharmacokinetics (PK), and efficacy of ABBV-291 monotherapy in pts with R/R B-NHL.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06667687

NCT06667687 | Study to Evaluate Adverse Events, ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M24-893

Study to Evaluate Adverse Events, Change in Disease ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-291 in adult participants in relapsed or ...

4. news.abbvie.com news.abbvie.com/2025-09-03-AbbVie-Announces-Updated-Results-From-Phase-2-EPCORE-R-NHL-6-Study-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Patients-With-Relapsed-Refractory-R-R-Diffuse-Large-B-Cell-Lymphoma-DLBCL

AbbVie Announces Updated Results From Phase 2 ... ICANS occurred in seven patients (7.6%), were primarily low grade (Grade 1-2), all resolved with a median time of three days, and no events led ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11258436/

Real life clinical outcomes of relapsed/refractory diffuse large ... After first‐line, ORR was 81.0% (316/390) including 72.6% complete remission (CR) and 8.5% partial remission (PR); 4.6% of patients had ...

6. ctsearchsupport.org ctsearchsupport.org/clinical-trials/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 drug, ABBV-291, to treat non-Hodgkin lymphoma (NHL) ... Clinical Trial Goal​​ To find out: The highest dose of ABBV-291 that's safe to give. If ABBV-291 is safe and works well to treat NHL that has ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/761324Orig1s000MultidisciplineR.pdf

761324Orig1s000 - accessdata.fda.gov Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood 130, 1800-1808. Dirks, N. L. ...