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

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
AbbVie
Study ID
NCT06667687
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ABBV-291 — DRUG
    Intravenous Infusion

Study Details

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.

Key Dates

Start date
Jan 16, 2025
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Nov 30, 2031

Study Design

Enrollment
165 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Escalation: Non-Hodgkin Lymphoma (NHL) ABBV-291
    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.
  • Experimental: Expansion: Diffuse Large B-Cell Lymphoma (DLBCL) ABBV-291
    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.
  • Experimental: Expansion: Follicular Lymphoma (FL) ABBV-291
    Participants with R/R FL will receive the RP1ED of ABBV-291, as part of the 74 month study duration.
  • Experimental: Optimization: Mantle Cell Lymphoma (MCL) ABBV-291 Dose A
    Participants with R/R MCL will receive the dose A of ABBV-291, as part of the 74 month study duration.
  • Experimental: Optimization: MCL ABBV-291 Dose B
    Participants with R/R MCL will receive the dose B of ABBV-291, as part of the 74 month study duration.
  • Experimental: Optimization: MCL ABBV-291 Dose C
    Participants with R/R MCL will receive the dose C of ABBV-291, as part of the 74 month study duration.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AE)s [ Time Frame: Up to 74 Months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Carolina BioOncology Institute /ID# 265259HuntersvilleNorth Carolina28078-
Willamette Valley Cancer Institute and Research Center /ID# 270945EugeneOregon97401-
Texas Oncology - Central/South Texas /ID# 270946AustinTexas78705-
START Mountain Region /ID# 267592West Valley CityUtah84119-3602-
Virginia Cancer Specialists - Fairfax /ID# 265082FairfaxVirginia22031-

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Carolina BioOncology Institute· Huntersville, NCWillamette Valley Cancer Institute and Research Center· Eugene, ORTexas Oncology - Central/South Texas· Austin, TXSTART Mountain Region· West Valley City, UTVirginia Cancer Specialists - Fairfax· Fairfax, VA

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