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A Study of ABBV-319 for Relapsed or Refractory Lymphoma and Leukemia

This study is testing an investigational drug called ABBV-319, given intravenously (through a vein), for adults with certain types of blood cancers that have returned or not responded to previous treatments. These cancers include diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). The main goals are to understand the safety of ABBV-319, how it moves through the body, and if it shows any early signs of helping to treat these conditions. Researchers will be looking for any side effects and how the disease activity changes. You may be eligible if you are an adult with one of these B-cell malignancies that requires treatment.

Study design
This is an interventional study with a planned enrollment of 154 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored for up to 30 months, and drug levels in the blood will be measured for up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05512390

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)

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~39 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:ABBV-319

At a glance

Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Dose-Limiting Toxicities (DLT)
Measured over Day 42
+6 more outcomes measured

Conditions

Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Follicular Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaFollicular Lymphoma

NCT05512390

Where you'd take part

This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Allina Health System /ID# 251782

    Minneapolis, Minnesotano site contact published

  • Asan Medical Center /ID# 263220

    Seoul, Seoul Teugbyeolsi, South Koreano site contact published

  • Baylor Sammons Cancer Center /ID# 247715

    Dallas, Texasno site contact published

  • Concord Repatriation General Hospital /ID# 249240

    Concord, New South Wales, Australiano site contact published

  • Cross Cancer Institute. /ID# 246717

    Edmonton, Alberta, Canadano site contact published

  • Hadassah Medical Center-Hebrew University /ID# 254885

    Jerusalem, Israelno site contact published

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 265198

    Madrid, Spainno site contact published

  • Hospital Universitario Marques de Valdecilla /ID# 262826

    Santander, Cantabria, Spainno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Dose-Limiting Toxicities (DLT)Day 42

    A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).

  • Number of Participants with Adverse Events (AE)Up to 30 Months

    AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  • Maximum Observed Serum Concentration (Cmax) of ABBV-319Up to 6 Months

    Maximum observed serum concentration of ABBV-319.

  • Time to Cmax (Tmax) of ABBV-319Up to 6 Months

    Time to Cmax of ABBV-319.

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-319Up to 6 Months

    Terminal phase elimination half-life of ABBV-319.

  • Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319Up to 6 Months

    Area under the serum concentration versus time curve (AUC) of ABBV-319.

  • Antidrug Antibody (ADA)Up to 6 Months

    Incidence and concentration of anti-drug antibodies.