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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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Concord Repatriation General Hospital /ID# 249240
Coordinator of this site? Confirm its status
ConcordAustraliaUnknown status
St Vincent's Hospital Melbourne /ID# 247624
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Fitzroy MelbourneAustraliaUnknown status
One Clinical Research Pty Ltd /ID# 248392
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NedlandsAustraliaUnknown status
Cross Cancer Institute. /ID# 246717
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
University Health Network_Princess Margaret Cancer Centre /ID# 243936
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Hospital Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Centre Hospitalier Universitaire de Nantes
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NantesFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Hospices Civils de Lyon
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Pierre-BéniteFranceCompleted
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceCompleted
Hadassah Medical Center-Hebrew University /ID# 254885
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JerusalemIsraelUnknown status
The Chaim Sheba Medical Center /ID# 254884
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Ramat GanIsraelUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyCompleted
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Humanitas Mirasole S.p.A.
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RozzanoItalyCompleted
Asan Medical Center /ID# 263220
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SeoulSouth KoreaUnknown status
Samsung Medical Center /ID# 263294
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SeoulSouth KoreaUnknown status
Seoul National University Hospital /ID# 263945
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SeoulSouth KoreaUnknown status
Novant Health Presbyterian Medical Center /ID# 246719
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CharlotteUnited StatesUnknown status
Baylor Sammons Cancer Center /ID# 247715
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Allina Health System /ID# 251782
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
University of Nebraska Medical Center /ID# 246715
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
University of Arizona Cancer Center - Tucson /ID# 247752
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.