ABBV-291 for Non-Hodgkin's Lymphoma

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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