RecruitingPhase 1NCT05512390

A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies


Sponsor

AbbVie

Enrollment

154 participants

Start Date

Apr 26, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. 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, questionnaires and side effects.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ABBV-319 — given by IV infusion — in patients with certain blood cancers that have come back or stopped responding to prior treatment, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). The trial starts by testing safety at different doses, then expands to specific cancer types. **You may be eligible if...** - You have been diagnosed with DLBCL, follicular lymphoma, or CLL that has relapsed or is no longer responding to treatment - You have measurable disease that can be tracked on imaging - Your blood and organ function meet the study's required levels - You have received prior standard treatments for your cancer **You may NOT be eligible if...** - You have untreated or poorly controlled brain involvement from your cancer - You have had a prior stem cell or bone marrow transplant recently - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-319

Intravenous (IV); Infusion


Locations(20)

University of Arizona Cancer Center - Tucson /ID# 247752

Tucson, Arizona, United States

Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232

Miami, Florida, United States

Allina Health System /ID# 251782

Minneapolis, Minnesota, United States

University of Nebraska Medical Center /ID# 246715

Omaha, Nebraska, United States

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246

New York, New York, United States

Novant Health Presbyterian Medical Center /ID# 246719

Charlotte, North Carolina, United States

Baylor Sammons Cancer Center /ID# 247715

Dallas, Texas, United States

University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234

San Antonio, Texas, United States

Concord Repatriation General Hospital /ID# 249240

Concord, New South Wales, Australia

St Vincent's Hospital Melbourne /ID# 247624

Fitzroy Melbourne, Victoria, Australia

One Clinical Research Pty Ltd /ID# 248392

Nedlands, Western Australia, Australia

Cross Cancer Institute /ID# 246717

Edmonton, Alberta, Canada

University Health Network_Princess Margaret Cancer Centre /ID# 243936

Toronto, Ontario, Canada

The Chaim Sheba Medical Center /ID# 254884

Ramat Gan, Tel Aviv, Israel

Hadassah Medical Center-Hebrew University /ID# 254885

Jerusalem, Israel

Seoul National University Hospital /ID# 263945

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center /ID# 263220

Seoul, Seoul Teugbyeolsi, South Korea

Samsung Medical Center /ID# 263294

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Universitario Marques de Valdecilla /ID# 262826

Santander, Cantabria, Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 265198

Madrid, Spain

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NCT05512390


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