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Evaluating ABBV-525 for treating B-cell cancers in adults

A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies

PHASE1 · AbbVie · NCT05618028

This study is testing a new oral medication called ABBV-525 to see if it can safely help adults with B-cell cancers.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie (industry)
Drugs / interventionsCAR-T, chimeric antigen receptor
Locations32 sites (Los Angeles, California and 31 other locations)
Trial IDNCT05618028 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-525, an investigational oral medication, in adult participants with B-cell malignancies. The trial consists of three parts: dose escalation, dose optimization, and dose expansion, where participants will receive varying doses of ABBV-525. Approximately 100 adults will be enrolled across multiple sites worldwide, with the study expected to last up to 64 months.

Who should consider this trial

Good fit: Ideal candidates include adults with third-line or later treatment B-cell malignancies such as diffuse large B-cell lymphoma or chronic lymphocytic leukemia.

Not a fit: Patients who have not received prior treatments or those with early-stage B-cell malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced B-cell malignancies.

How similar studies have performed: Other studies have shown promise with similar investigational therapies for B-cell malignancies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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) who are 3L+, +/- cysteine-to-serine point mutation at residue 481 of BTK-domain active site (C481S 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 non-germinal center B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimeric antigen receptor T-cells (CAR-T)/Hematopoietic cell transplant (HCT) relapsed/refractory (R/R) and/or ineligible with histology based on WHO criteria, with measurable disease requiring treatment.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
* 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 Criteria:

* 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 hepatitis B or C infection.
* 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 (eg, polymerase chain reaction) test or 3 negative antigen test results at least 24 hours apart.

Where this trial is running

Los Angeles, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, B Cell Malignancies, Non-Hodgkin's Lymphoma, B-cell Malignancies, ABBV-525, Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.