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Study of ABBV-525 for B-Cell Malignancies

This study is testing an investigational drug called ABBV-525, given as an oral tablet, for adults with B-cell malignancies (cancers of certain white blood cells). The main goals are to understand the safety of ABBV-525, including any side effects, and to see how well it works. Participants will receive different doses of ABBV-525. The study is looking for adults aged 18 and older who have specific types of B-cell malignancies, such as Diffuse Large B-Cell Lymphoma or Chronic Lymphocytic Leukemia, and have received at least two prior treatments. The study is currently recruiting participants.

Study design
This is an interventional study with an estimated enrollment of 78 participants. Participants will receive ABBV-525 at different doses.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and tumor lysis syndrome (a complication of cancer treatment) for up to approximately 64 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.

NCT05618028

Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
AbbVie
~78 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:ABBV-525

At a glance

Recruiting sites
0 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Adverse Events (AE)
Measured over Up to Approximately 64 Months
+8 more outcomes measured

Conditions

Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
B Cell Malignancies
Non-Hodgkin's Lymphoma

Explore related trials

B-Cell Malignant NeoplasmChronic Lymphocytic LeukemiaDiffuse Large B-Cell LymphomaNon-Hodgkin LymphomaSmall Lymphocytic Lymphoma

Where it's being run

39 sites across 28 states
Spain4
Seoul Teugbyeolsi3
Indiana2
New South Wales2
Victoria2
Central District2
Taiwan2
United Kingdom2

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

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

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the following third line or later of treatment (3L)+ mature B-cell malignancies, from the World Health Organization (WHO)-defined histologies as defined in the protocol.
Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) with histology based on WHO criteria, with measurable disease requiring treatment as defined by the International Workshop on Chronic Lymphocytic Leukemia (iwCLL).
Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, with measurable disease requiring treatment.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
Participant has a life expectancy \>= 12 weeks.
Adequate hematological and hepatic function as defined in the protocol.
Must have archival or freshly collected tumor tissue for correlative studies before study enrollment.
Participants with prior central nervous system (CNS) disease that has been effectively treated may be eligible.
Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.

Exclusion

Known active CNS disease, or primary CNS lymphoma.
Known bleeding disorders.
Known history of stroke or intracranial hemorrhage within 12 months prior to first dose of study treatment.
Uncontrolled active systemic infection, or active cytomegalovirus infection.
Active and/or chronic hepatitis B or C infection and/or the criteria listed in the protocol.
Known history of human immunodeficiency virus (HIV).
Known active COVID-19 infection. Participant must not have signs/symptoms associated with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection during screening. If participant has signs/symptoms suggestive of COVID-19 infection, the participant must have a negative molecular (e.g., polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.

What this trial measures

  • Number of Participants With Adverse Events (AE)Up to Approximately 64 Months

    An AE is 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. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.

  • Number of Participants With Dose-Limiting Toxicities (DLT)Up to Approximately 28 Days

    A DLT is defined as any 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 Tumor Lysis Syndrome (TLS)Up to Approximately 64 Months

    TLS is confirmed by evaluation of electrolyte and fluid status and renal status including urine output.

  • Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory ParametersUp to Approximately 64 Months

    Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator will assess the results for clinical significance.

  • Number of Participants With Clinically Significant Changes From Baseline in Vital Sign ParametersUp to Approximately 64 Months

    Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.

  • Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)Up to Approximately 64 Months

    A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.

  • Maximum Observed Plasma Concentration (Cmax) of ABBV-525Up to 12 Months

    Maximum observed plasma concentration of ABBV-525.

  • Time to Cmax (Tmax) of ABBV-525Up to 12 Months

    Time to Cmax of ABBV-525.

  • Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525Up to 12 Months

    Area under the plasma concentration-time curve of ABBV-525.