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

Recruiting at 28 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 tests a new drug, ABBV-319, for certain blood cancers, specifically diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). The goal is to assess the drug's safety and effectiveness for individuals whose cancer has returned or resisted previous treatments. Participants will receive the drug in cycles, with researchers adjusting the dosage to determine the optimal amount for future studies. Those dealing with these relapsed or hard-to-treat cancers might be suitable for this study. Regular clinic or hospital visits are required for monitoring and testing. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this new drug.

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.

Is there any evidence suggesting that ABBV-319 is likely to be safe for humans?

Research shows that ABBV-319, the treatment being tested, targets a protein called CD19, often found in B-cell cancers like non-Hodgkin's lymphoma and certain leukemias. Studies support that targeting this protein can help treat these types of cancer.

So far, ABBV-319 has demonstrated strong cancer-fighting effects in lab studies. However, this trial remains in an early stage, focusing primarily on assessing its safety for humans. Early-stage trials like this one usually concentrate on safety and determining the right dose before evaluating the treatment's effectiveness.

Since ABBV-319 is in the early testing phase, limited information exists on its side effects in people. Participants in the trial will report any side effects they experience, helping to determine how well the drug is tolerated. This information will be crucial for understanding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for non-Hodgkin's lymphoma and chronic lymphocytic leukemia, which typically include chemotherapy and targeted therapies, ABBV-319 offers a novel approach. ABBV-319 is unique because it targets a specific protein on the surface of cancer cells, potentially leading to more precise and effective treatment. Researchers are excited about this treatment as it could provide a more targeted attack on cancer cells with potentially fewer side effects compared to traditional therapies. Additionally, the dose escalation aspect of this study could help identify the optimal dose to maximize benefits while minimizing risks.

What evidence suggests that ABBV-319 might be an effective treatment for relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, and chronic lymphocytic leukemia?

Research shows that ABBV-319 may help treat certain blood cancers. In studies, a single dose of ABBV-319 led to noticeable tumor shrinkage and strong anti-cancer effects in B-cell cancers. In this trial, participants with Diffuse Large B-cell Lymphoma (DLBCL) will receive ABBV-319, which has shown better results than several doses of other treatments in previous studies. Participants with Chronic Lymphocytic Leukemia (CLL) will also receive ABBV-319, which proved more effective than a similar antibody treatment in past research. For those with Follicular Lymphoma, early results suggest ABBV-319 has a good chance of progressing successfully through clinical trials. These findings indicate that ABBV-319 could be a strong option for managing these difficult conditions. ^{1 2 4 6 7}

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05512390

NCT05512390 | A Study to Assess the Adverse Events, ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or ...

2. ashpublications.org ashpublications.org/blood/article/144/7/757/516007/ABBV-319-a-CD19-targeting-glucocorticoid-receptor

ABBV-319: a CD19-targeting glucocorticoid receptor ... Notably, ABBV-319 displayed superior efficacy compared with afucosylated CD19 mAb in human CD34+ peripheral blood mononuclear cell–engrafted NSG ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11375461/

ABBV-319: a CD19-targeting glucocorticoid receptor ... ABBV-319 delivers a glucocorticoid receptor modulator (GRM) payload that induces pronounced anti-tumor activity in B-cell malignancies.

4. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/abbv-319-abbvie-relapsed-chronic-lymphocytic-leukemia-cll-likelihood-of-approval/

ABBV-319 by AbbVie for Relapsed Chronic Lymphocytic ... According to GlobalData, Phase I drugs for Relapsed Chronic Lymphocytic Leukemia (CLL) have a 73% phase transition success rate (PTSR) indication benchmark for ...

5. withpower.com withpower.com/trial/phase-1-diffuse-large-b-cell-lymphoma-dlbcl-7-2022-5b520

ABBV-319 for Non-Hodgkin's Lymphoma and Chronic ... 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.

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M22-716

M22-716 A study to assess the adverse events, change in disease activity, and how intravenously infused ABBV-319 moves through the bodies of adult participants.

7. careacross.com careacross.com/clinical-trials/trial/NCT05512390

A Study to Assess the Adverse Events Change in Disease ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or ...