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RECRUITING
NCT06667687
PHASE1

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

Sponsor: AbbVie

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

165

Start Date

2025-01-16

Completion Date

2031-11

Last Updated

2026-01-26

Healthy Volunteers

No

Interventions

DRUG

ABBV-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