ABBV-319 for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Recruiting at 23 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Active CNS disease, Active infection, ECOG >= 2

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

154 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called ABBV-319 for adults with certain blood cancers that have come back or didn't respond to treatment. The drug is given in regular intervals, starting with small amounts and gradually increasing to find the most effective amount. The goal is to see if ABBV-319 is safe and effective in reducing cancer activity.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Adults with certain types of blood cancers (DLBCL, FL, or CLL) that have come back or didn't respond to treatment can join. They must be in good physical condition (ECOG 0-1), meet specific lab value criteria, and have measurable disease. Those who've had CD19-targeting therapy need a recent biopsy. People with active infections, uncontrolled conditions, or CNS lymphoma cannot participate.

Inclusion Criteria

Participant must have measurable disease, as defined by the 2014 Lugano Classification

I have a B-cell cancer diagnosis needing treatment, as per WHO standards.

I am fully active or can carry out light work.

Exclusion Criteria

I do not have any active infections or uncontrolled health conditions.

I have an active brain disease or primary brain lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating intravenously infused doses of ABBV-319 in 21-day cycles until the Phase 2 dose is determined

Variable, based on dose determination

Regular visits at an approved institution

Dose Expansion

Participants receive intravenously infused ABBV-319 in 21-day cycles to determine change in disease activity

21-day cycles

Regular visits at an approved institution

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-319

Trial Overview The trial is testing ABBV-319's safety and how it affects the body when given through an IV to adults with relapsed/refractory B-cell lymphomas. It includes two phases: finding the best dose and then seeing how well it works at that dose across multiple sites worldwide.

How Is the Trial Designed?

Group I: Dose Escalation ABBV-319 Experimental Treatment 1 Intervention

Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the doses of ABBV-319 that will be used in the next phase are determined.

Group II: (ABBV-319) Follicular Lymphoma (FL) Participants Experimental Treatment 1 Intervention

Participants with R/R FL will receive ABBV-319 in 21-day cycles.

Group III: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants Experimental Treatment 1 Intervention

Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.

Group IV: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants Experimental Treatment 1 Intervention

Participants with R/R CLL will receive ABBV-319 in 21-day cycles.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois