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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California Los Angeles /ID# 246357
  Los Angeles, California, United States Recruiting
• Yale University School of Medicine /ID# 259081
  New Haven, Connecticut, United States Recruiting
• Mount Sinai Medical Center-Miami Beach /ID# 248251
  Miami Beach, Florida, United States Recruiting
• Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
  Fort Wayne, Indiana, United States Recruiting
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
  Indianapolis, Indiana, United States Recruiting
• START Midwest /ID# 252359
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Emavusertib plus zanubrutinib for CLL and other B‑cell cancers

  This test will see if adding emavusertib to the BTK inhibitor zanubrutinib can reduce measurable residual disease in adults with chronic lymphocytic leukemia or other B‑cell malignancies.

  Recruiting at 11 sites Phase 2 Curis, Inc. · Miami Beach, Florida and 10 other locations · NCT07271667

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

• Nemtabrutinib plus pembrolizumab for Richter transformation (DLBCL subtype)

  This phase II trial tests whether combining nemtabrutinib and pembrolizumab can shrink tumors and help people whose chronic lymphocytic leukemia has transformed into diffuse large B‑cell lymphoma (Richter transformation).

  Recruiting Phase 2 Roswell Park Cancer Institute · Buffalo, New York · NCT06863402

• Evaluating vaccine responses in patients with multiple myeloma and non-Hodgkin lymphoma after CAR-T treatment

  This study tests how well vaccines work in people with multiple myeloma and non-Hodgkin lymphoma after they have received CAR-T treatment.

  Recruiting OHSU Knight Cancer Institute · Portland, Oregon · NCT06784167

• Gene therapy for certain blood cancers

  This study is testing a new gene therapy called VNX-101 to see if it can help people with certain types of blood cancers that haven't responded to other treatments.

  Recruiting at 11 sites Phase 1/2 Vironexis Biotherapeutics Inc. · Duarte, California and 10 other locations · NCT06533579

• Seeing CXCR4 in lymphoma and leukemia with a new PET tracer

  This study tests a new PET tracer called 18F-BL40 to see if it can image CXCR4-expressing cancers and compares it with the standard 18F-FDG in adults with various blood cancers.

  Recruiting British Columbia Cancer Agency · Vancouver, British Columbia · NCT06224309

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.