RecruitingPhase 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 First-In-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV 291 as Monotherapy and in Combination in Non-Hodgkin's Lymphoma


Sponsor

AbbVie

Enrollment

165 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new intravenous drug called ABBV-291 in adults with certain types of B-cell lymphoma — a cancer of the immune system's white blood cells. The study starts with a dose-finding phase across several lymphoma types, then expands to focus on specific types including diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. **You may be eligible if...** - You are an adult with a confirmed diagnosis of a B-cell lymphoma (such as DLBCL, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, or Waldenstrom's macroglobulinemia) - Your disease requires treatment and has measurable tumors on scans - You have tried and exhausted available standard treatments - You are in good enough health to participate **You may NOT be eligible if...** - You have certain heart conditions or active serious infections - You have had certain recent transplants or prior specific treatments that conflict with this drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-291

Intravenous Infusion


Locations(14)

Carolina BioOncology Institute /ID# 265259

Huntersville, North Carolina, United States

Willamette Valley Cancer Institute and Research Center /ID# 270945

Eugene, Oregon, United States

Texas Oncology - Central/South Texas /ID# 270946

Austin, Texas, United States

START Mountain Region /ID# 267592

West Valley City, Utah, United States

Virginia Cancer Specialists - Fairfax /ID# 265082

Fairfax, Virginia, United States

St Vincent's Hospital Melbourne /ID# 261664

Fitzroy Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital /ID# 268579

Nedlands, Western Australia, Australia

Hadassah Medical Center-Hebrew University /ID# 261658

Jerusalem, Jerusalem, Israel

Tel Aviv Sourasky Medical Center /ID# 261659

Tel Aviv, Tel Aviv, Israel

Aichi Cancer Center /ID# 267471

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East /ID# 261775

Kashiwa-shi, Chiba, Japan

The Cancer Institute Hospital Of JFCR /ID# 267470

Koto-ku, Tokyo, Japan

The Christie /ID# 267177

Manchester, United Kingdom

University Hospitals Plymouth NHS Trust /ID# 267174

Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06667687


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