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NCT Number: 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)

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.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Chronic Disease Chronic Lymphocytic Leukemia Disease Attributes Follicular Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Concord Repatriation General Hospital /ID# 249240, Concord, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-319

Drug

Intravenous (IV); Infusion

Primary outcomes

  1. Number of Dose-Limiting Toxicities (DLT)

    Time frame: 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).

  2. Number of Participants with Adverse Events (AE)

    Time frame: 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.

  3. Maximum Observed Serum Concentration (Cmax) of ABBV-319

    Time frame: Up to 6 Months

    Maximum observed serum concentration of ABBV-319.

  4. Time to Cmax (Tmax) of ABBV-319

    Time frame: Up to 6 Months

    Time to Cmax of ABBV-319.

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-319

    Time frame: Up to 6 Months

    Terminal phase elimination half-life of ABBV-319.

  6. Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319

    Time frame: Up to 6 Months

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

  7. Antidrug Antibody (ADA)

    Time frame: Up to 6 Months

    Incidence and concentration of anti-drug antibodies.

Secondary outcomes

  1. Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria

    Time frame: Up to 6 Months

    Number of participants with response of PR or better per disease-specific criteria.

  2. Duration of Response (DOR)

    Time frame: Up to 6 Months

    DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.

  3. Time to Response

    Time frame: Up to 6 Months

    Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.

  4. Progression Free Survival (PFS) Time

    Time frame: Up to 30 Months

    PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier.

  5. Overall survival (OS) Time

    Time frame: Up to 30 Months

    OS is defined as time from first study treatment to death due to any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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