Diffuse Large B-Cell LymphomaPhase 1NCT05618028
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
A Phase 1 study testing ABBV-525 in people with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia, run by AbbVie at 39 sites in 10 countries.
Trial summary
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, B Cell Malignancies
- What is being tested?
- ABBV-525
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 39 sitesin 10 countries
- Study dates
- 4 Apr 2023to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
39 sites in 10 countries.
39 sites in 10 countries
United States13 sites
Atrium Health Levine Cancer Institute /ID# 246363
Charlotte, North Carolina, 28204
University Of Cincinnati Medical Center /ID# 262288
Cincinnati, Ohio, 45219
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, Indiana, 46804
START Midwest /ID# 252359
Grand Rapids, Michigan, 49546
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, Texas, 77030
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis, Indiana, 46202-5116
University of California Los Angeles Medical Center /ID# 246357
Los Angeles, California, 90095
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, Florida, 33140-2948
Yale University School of Medicine /ID# 259081
New Haven, Connecticut, 06510
Tulane Cancer Center Clinic /ID# 249586
New Orleans, Louisiana, 70112
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, New York, 10065-6007
University of Utah Health Hospital /ID# 259924
Salt Lake City, Utah, 84132
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma, Washington, 98405
Spain5 sites
Hospital Universitario Vall de Hebron /ID# 245475
Barcelona, 08035
Hospital Clinic de Barcelona /ID# 246543
Barcelona, 08036
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario Ramon y Cajal /ID# 246540
Madrid, 28034
Hospital Universitario 12 de Octubre /ID# 246538
Madrid, 28041
Australia4 sites
Bankstown-Lidcombe Hospital /ID# 260191
Bankstown, New South Wales, 2200
Monash Health - Monash Medical Centre /ID# 246366
Clayton, Victoria, 3168
The Alfred Hospital /ID# 248592
Melbourne, Victoria, 3004
Orange Health Service /ID# 260473
Orange, New South Wales, 2800
Israel4 sites
Shamir Medical Center /ID# 257711
Beer Ya'akov, Central District, 70300
Hadassah Medical Center-Hebrew University /ID# 251441
Jerusalem, Jerusalem, 91120
Rabin Medical Center. /ID# 257665
Petah Tikva, Central District, 4941492
The Chaim Sheba Medical Center /ID# 251442
Ramat Gan, Tel Aviv, 5265601
South Korea3 sites
Seoul National University Hospital /ID# 266340
Seoul, Seoul Teugbyeolsi, 03080
Asan Medical Center /ID# 266341
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center /ID# 266415
Seoul, Seoul Teugbyeolsi, 06351
United Kingdom3 sites
Leeds Teaching Hospitals NHS Trust /ID# 245470
Leeds, West Yorkshire, LS9 7TF
The Royal Marsden NHS Foundation Trust /ID# 250324
London, SW3 6JJ
The Christie Hospital /ID# 250325
Manchester, M20 4BX
Belgium2 sites
UZ Gent /ID# 246462
Ghent, Oost-Vlaanderen, 9000
Universitair Ziekenhuis Leuven /ID# 246461
Leuven, Vlaams-Brabant, 3000
France2 sites
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille, Nord, 59037
IUCT Oncopole /ID# 259409
Toulouse, Occitanie, 31059
Taiwan2 sites
China Medical University Hospital /ID# 266414
Taichung, 40447
National Taiwan University Hospital /ID# 266343
Taipei, 100
Germany1 site
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062
Berlin, 13353
About this study
Official title: A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.
ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 150 adult participants will be enrolled in the study across sites worldwide.
Read more
In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months.
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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
- Conditions
- Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, B Cell Malignancies, Non-Hodgkin's Lymphoma
- Being tested
- ABBV-525
- Keywords
- Diffuse Large B-Cell Lymphoma, B-cell Malignancies, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, ABBV-525, Cancer
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Non-Hodgkin, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-525Drug
Oral; Tablet
| Study group | Role | What they receive |
|---|---|---|
| ABBV-525 Dose Escalation | Experimental | Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period. Receives: Drug: ABBV-525 |
| ABBV-525 Dose Optimization | Experimental | Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period. Receives: Drug: ABBV-525 |
| ABBV-525 Dose Expansion | Experimental | Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period. Receives: Drug: ABBV-525 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AE)
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.
Measured: Up to Approximately 64 Months
Number of Participants With Dose-Limiting Toxicities (DLT)
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).
Measured: Up to Approximately 28 Days
Number of Tumor Lysis Syndrome (TLS)
TLS is confirmed by evaluation of electrolyte and fluid status and renal status including urine output.
Measured: Up to Approximately 64 Months
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator will assess the results for clinical significance.
Measured: Up to Approximately 64 Months
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
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.
Measured: Up to Approximately 64 Months
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
Measured: Up to Approximately 64 Months
Maximum Observed Plasma Concentration (Cmax) of ABBV-525
Maximum observed plasma concentration of ABBV-525.
Measured: Up to 12 Months
Time to Cmax (Tmax) of ABBV-525
Time to Cmax of ABBV-525.
Measured: Up to 12 Months
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525
Area under the plasma concentration-time curve of ABBV-525.
Measured: Up to 12 Months
Secondary outcomes (2)
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR)/very good partial response (VGPR)/partial response (PR) in participants receiving at least 1 dose of study drug.
Measured: Up to Approximately 64 Months
Duration of Response (DOR)
DOR is defined for participants achieving CR/VGPR/PR as the time from the initial response per Investigator review to disease progression or death of any cause, whichever occurs earlier.
Measured: Up to Approximately 64 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start4 Apr 2023
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618028
- Sponsor's protocol ID
- M23-324
- Other IDs
- 2022-503136-13, 2022-503136-13-00
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
- ClinicalTrials.gov ID
- NCT05618028
- Acronym / sponsor ID
- M23-324
- Conditions
- Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, B Cell Malignancies, Non-Hodgkin's Lymphoma
- Keywords
- Diffuse Large B-Cell Lymphoma, B-cell Malignancies, Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, ABBV-525, Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.
ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 150 adult participants will be enrolled in the study across sites worldwide.
In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study is up to 64 months.
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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABBV-525 Dose Escalation | Experimental | Drug: ABBV-525Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period. |
| ABBV-525 Dose Optimization | Experimental | Drug: ABBV-525Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period. |
| ABBV-525 Dose Expansion | Experimental | Drug: ABBV-525Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-525Oral; Tablet | Drug | ABBV-525 Dose Escalation, ABBV-525 Dose Expansion, ABBV-525 Dose Optimization |
Primary outcome
Number of Participants With Adverse Events (AE)
Time frame: 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)
Time frame: 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)
Time frame: 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 Parameters
Time frame: Up 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 Parameters
Time frame: Up 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)
Time frame: 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-525
Time frame: Up to 12 Months
Maximum observed plasma concentration of ABBV-525.
Time to Cmax (Tmax) of ABBV-525
Time frame: Up to 12 Months
Time to Cmax of ABBV-525.
Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525
Time frame: Up to 12 Months
Area under the plasma concentration-time curve of ABBV-525.
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: Up to Approximately 64 Months
Duration of Response (DOR)
Time frame: Up to Approximately 64 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
39 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-525 in people with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia, run by AbbVie at 39 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Spain, Australia, Israel, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AE) (time frame: Up to Approximately 64 Months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.