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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
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
Conditions
Interventions
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