Actively Recruiting
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
Led by AbbVie · Updated on 2026-01-26
165
Participants Needed
14
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with confirmed diagnosis of specific B-cell lymphomas including mantle cell lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia, diffuse large B-cell lymphoma (various subtypes), and follicular lymphoma Grades 1 to 3B
- Participants relapsed, refractory, or intolerant to at least two prior effective therapies, with no suitable available treatment options
- Participants with indolent NHL must meet specific disease treatment criteria
- Stable off immunosuppression for at least 3 months if previously received allogeneic stem cell transplant
- Consent to provide fresh tumor biopsy unless waived for safety or technical reasons
- Previous treatment with CD79b-targeting therapy with tumor biopsy available or waived
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Laboratory values meeting protocol criteria before first dose
- Availability of suitable baseline tumor tissue for immunohistochemistry testing or waiver granted
You will not qualify if you...
- History of interstitial lung disease or pneumonitis requiring systemic steroids, or active lung disease
- Treatment with anticancer therapies including chemotherapy, radiotherapy, investigational or biologic agents within 14 days before study drug
- Treatment with CD79b-directed agents within 4 weeks before study drug
- Prior treatment with antibody drug conjugates containing topoisomerase I inhibitor
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Carolina BioOncology Institute /ID# 265259
Huntersville, North Carolina, United States, 28078
Completed
2
Willamette Valley Cancer Institute and Research Center /ID# 270945
Eugene, Oregon, United States, 97401
Actively Recruiting
3
Texas Oncology - Central/South Texas /ID# 270946
Austin, Texas, United States, 78705
Actively Recruiting
4
START Mountain Region /ID# 267592
West Valley City, Utah, United States, 84119-3602
Completed
5
Virginia Cancer Specialists - Fairfax /ID# 265082
Fairfax, Virginia, United States, 22031
Completed
6
St Vincent's Hospital Melbourne /ID# 261664
Fitzroy Melbourne, Victoria, Australia, 3065
Actively Recruiting
7
Sir Charles Gairdner Hospital /ID# 268579
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
8
Hadassah Medical Center-Hebrew University /ID# 261658
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
9
Tel Aviv Sourasky Medical Center /ID# 261659
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
10
Aichi Cancer Center /ID# 267471
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
11
National Cancer Center Hospital East /ID# 261775
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
12
The Cancer Institute Hospital Of JFCR /ID# 267470
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
13
The Christie /ID# 267177
Manchester, United Kingdom, M20 4BX
Actively Recruiting
14
University Hospitals Plymouth NHS Trust /ID# 267174
Plymouth, United Kingdom, PL6 5FP
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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