NCT05512390Active, not recruitingPhase 1
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 First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 22 Aug 2022
- Start date
- 26 Apr 2023
- Primary completion date
- Feb 2027
- Lead sponsor
- AbbVie
- NCT number
- NCT05512390
- EU CT number
- 2023-505479-56-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 26 Apr 2023 to the primary completion date, Feb 2027
- 30 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known active central nervous system (CNS) disease, or primary CNS lymphoma.
- Known active infection or clinically significant uncontrolled conditions as per the protocol.
Other
- Eastern Cooperative Oncology Group (ECOG) performance status \>= 2.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Concord Repatriation General Hospital /ID# 249240 Coordinator of this site? Confirm its status | Concord | Australia | Unknown status |
| St Vincent's Hospital Melbourne /ID# 247624 Coordinator of this site? Confirm its status | Fitzroy Melbourne | Australia | Unknown status |
| One Clinical Research Pty Ltd /ID# 248392 Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Cross Cancer Institute. /ID# 246717 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| University Health Network_Princess Margaret Cancer Centre /ID# 243936 Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Completed |
| Hadassah Medical Center-Hebrew University /ID# 254885 Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| The Chaim Sheba Medical Center /ID# 254884 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Completed |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Completed |
| Asan Medical Center /ID# 263220 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center /ID# 263294 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital /ID# 263945 Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Novant Health Presbyterian Medical Center /ID# 246719 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Baylor Sammons Cancer Center /ID# 247715 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Allina Health System /ID# 251782 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Medical Center /ID# 246715 Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| University of Arizona Cancer Center - Tucson /ID# 247752 Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.