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New drug ABBV-319 takes aim at Hard-to-Treat blood cancers

NCT ID NCT05512390

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This early-stage trial tests an investigational drug called ABBV-319 in about 154 adults with certain B-cell cancers (diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia) that have returned or not responded to standard treatments. The study has two parts: first, finding a safe dose, then checking how well that dose controls the cancer. Participants receive the drug by IV every 21 days and are closely monitored for side effects and tumor response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-319 (an investigational drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with certain B-cell cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, not yet on effectiveness. The drug may not shrink tumors or could cause serious side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

39 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol. * For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol. * Laboratory values meeting the criteria noted in the protocol. * For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected. * Participant must have measurable disease, as defined by the 2014 Lugano Classification. Exclusion Criteria: * Known active central nervous system (CNS) disease, or primary CNS lymphoma. * Known active infection or clinically significant uncontrolled conditions as per the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status \>= 2.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma neoplasm relapsed/refractory diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphocytic leukemia Diffuse large B-cell lymphoma Follicular lymphoma

Contacts and locations

Locations

  • Allina Health System /ID# 251782

    Minneapolis, Minnesota, 55407-1321, United States

  • Asan Medical Center /ID# 263220

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Baylor Sammons Cancer Center /ID# 247715

    Dallas, Texas, 75246, United States

  • Concord Repatriation General Hospital /ID# 249240

    Concord, New South Wales, 2139, Australia

  • Cross Cancer Institute. /ID# 246717

    Edmonton, Alberta, T6G 1Z2, Canada

  • Hadassah Medical Center-Hebrew University /ID# 254885

    Jerusalem, 91120, Israel

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 265198

    Madrid, 28040, Spain

  • Hospital Universitario Marques de Valdecilla /ID# 262826

    Santander, Cantabria, 39008, Spain

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

    New York, New York, 10065-6007, United States

  • Novant Health Presbyterian Medical Center /ID# 246719

    Charlotte, North Carolina, 28204, United States

  • One Clinical Research Pty Ltd /ID# 248392

    Nedlands, Western Australia, 6009, Australia

  • Samsung Medical Center /ID# 263294

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Seoul National University Hospital /ID# 263945

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • St Vincent's Hospital Melbourne /ID# 247624

    Fitzroy Melbourne, Victoria, 3065, Australia

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

    Miami, Florida, 33136, United States

  • The Chaim Sheba Medical Center /ID# 254884

    Ramat Gan, Tel Aviv, 5265601, Israel

  • University Health Network_Princess Margaret Cancer Centre /ID# 243936

    Toronto, Ontario, M5G 2M9, Canada

  • University of Arizona Cancer Center - Tucson /ID# 247752

    Tucson, Arizona, 85724, United States

  • University of Nebraska Medical Center /ID# 246715

    Omaha, Nebraska, 68198, United States

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

    San Antonio, Texas, 78229, United States

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