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Diffuse Large B-Cell LymphomaPhase 1NCT05512390

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)

A Phase 1 study testing ABBV-319 in people with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia, run by AbbVie at 20 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ABBV-319
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
20 sitesin 6 countries
Study dates
26 Apr 2023to Feb 2027
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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 6 countries.

20 sites in 6 countries

United States8 sites

  • Novant Health Presbyterian Medical Center /ID# 246719

    Charlotte, North Carolina, 28204

  • Baylor Sammons Cancer Center /ID# 247715

    Dallas, Texas, 75246

  • Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232

    Miami, Florida, 33136

  • Allina Health System /ID# 251782

    Minneapolis, Minnesota, 55407-1321

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246

    New York, New York, 10065-6007

  • University of Nebraska Medical Center /ID# 246715

    Omaha, Nebraska, 68198

  • University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234

    San Antonio, Texas, 78229

  • University of Arizona Cancer Center - Tucson /ID# 247752

    Tucson, Arizona, 85724

Other trials in United States

Australia3 sites

  • Concord Repatriation General Hospital /ID# 249240

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne /ID# 247624

    Fitzroy Melbourne, Victoria, 3065

  • One Clinical Research Pty Ltd /ID# 248392

    Nedlands, Western Australia, 6009

Other trials in Australia

South Korea3 sites

  • Seoul National University Hospital /ID# 263945

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center /ID# 263220

    Seoul, Seoul Teugbyeolsi, 05505

  • Samsung Medical Center /ID# 263294

    Seoul, Seoul Teugbyeolsi, 06351

Other trials in South Korea

Canada2 sites

  • Cross Cancer Institute. /ID# 246717

    Edmonton, Alberta, T6G 1Z2

  • University Health Network_Princess Margaret Cancer Centre /ID# 243936

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Israel2 sites

  • Hadassah Medical Center-Hebrew University /ID# 254885

    Jerusalem, 91120

  • The Chaim Sheba Medical Center /ID# 254884

    Ramat Gan, Tel Aviv, 5265601

Other trials in Israel

Spain2 sites

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 265198

    Madrid, 28040

  • Hospital Universitario Marques de Valdecilla /ID# 262826

    Santander, Cantabria, 39008

Other trials in Spain

About this study

Official 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

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.

Read more

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.

Being tested
ABBV-319
Keywords
Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Cancer, B-Cell Malignancies, ABBV-319
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-319Drug

    Intravenous (IV); Infusion

Study groups in NCT05512390
Study groupRoleWhat they receive
Dose Escalation ABBV-319ExperimentalParticipants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the doses of ABBV-319 that will be used in the next phase are determined.
Receives: Drug: ABBV-319
(ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) ParticipantsExperimentalParticipants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
Receives: Drug: ABBV-319
(ABBV-319) Follicular Lymphoma (FL) ParticipantsExperimentalParticipants with R/R FL will receive ABBV-319 in 21-day cycles.
Receives: Drug: ABBV-319
(ABBV-319) Chronic Lymphocytic Leukemia (CLL) ParticipantsExperimentalParticipants with R/R CLL will receive ABBV-319 in 21-day cycles.
Receives: Drug: ABBV-319

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Dose-Limiting Toxicities (DLT)

    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).

    Measured: Day 42

  2. Number of Participants with Adverse Events (AE)

    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.

    Measured: Up to 30 Months

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

    Maximum observed serum concentration of ABBV-319.

    Measured: Up to 6 Months

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

    Time to Cmax of ABBV-319.

    Measured: Up to 6 Months

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

    Terminal phase elimination half-life of ABBV-319.

    Measured: Up to 6 Months

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

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

    Measured: Up to 6 Months

  7. Antidrug Antibody (ADA)

    Incidence and concentration of anti-drug antibodies.

    Measured: Up to 6 Months

Secondary outcomes (5)

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

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

    Measured: Up to 6 Months

  2. Duration of Response (DOR)

    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.

    Measured: Up to 6 Months

  3. Time to Response

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

    Measured: Up to 6 Months

  4. Progression Free Survival (PFS) Time

    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.

    Measured: Up to 30 Months

  5. Overall survival (OS) Time

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

    Measured: Up to 30 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start26 Apr 2023
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05512390
Sponsor's protocol ID
M22-716
Status last verified
Aug 2026
First submitted
22 Aug 2022
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-319 in people with Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia, run by AbbVie at 20 sites in 6 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 5 inclusion and 3 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 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Australia, South Korea, Canada, Israel and 1 more country. 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 Dose-Limiting Toxicities (DLT) (time frame: Day 42). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05512390.

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 28 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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