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
1 other identifier
interventional
154
6 countries
20
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2023
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 23, 2022
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
January 16, 2026
January 1, 2026
3.8 years
August 22, 2022
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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).
Day 42
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.
Up to 30 Months
Maximum Observed Serum Concentration (Cmax) of ABBV-319
Maximum observed serum concentration of ABBV-319.
Up to 6 Months
Time to Cmax (Tmax) of ABBV-319
Time to Cmax of ABBV-319.
Up to 6 Months
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Terminal phase elimination half-life of ABBV-319.
Up to 6 Months
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Up to 6 Months
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Up to 6 Months
Secondary Outcomes (5)
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Up to 6 Months
Duration of Response (DOR)
Up to 6 Months
Time to Response
Up to 6 Months
Progression Free Survival (PFS) Time
Up to 30 Months
Overall survival (OS) Time
Up to 30 Months
Study Arms (4)
Dose Escalation ABBV-319
EXPERIMENTALParticipants 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.
(ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
EXPERIMENTALParticipants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
(ABBV-319) Follicular Lymphoma (FL) Participants
EXPERIMENTALParticipants with R/R FL will receive ABBV-319 in 21-day cycles.
(ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
EXPERIMENTALParticipants with R/R CLL will receive ABBV-319 in 21-day cycles.
Interventions
Intravenous (IV); Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (20)
University of Arizona Cancer Center - Tucson /ID# 247752
Tucson, Arizona, 85724, United States
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami, Florida, 33136, United States
Allina Health System /ID# 251782
Minneapolis, Minnesota, 55407-1321, United States
University of Nebraska Medical Center /ID# 246715
Omaha, Nebraska, 68198, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York, New York, 10065-6007, United States
Novant Health Presbyterian Medical Center /ID# 246719
Charlotte, North Carolina, 28204, United States
Baylor Sammons Cancer Center /ID# 247715
Dallas, Texas, 75246, United States
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas, 78229, United States
Concord Repatriation General Hospital /ID# 249240
Concord, New South Wales, 2139, Australia
St Vincent's Hospital Melbourne /ID# 247624
Fitzroy Melbourne, Victoria, 3065, Australia
One Clinical Research Pty Ltd /ID# 248392
Nedlands, Western Australia, 6009, Australia
Cross Cancer Institute /ID# 246717
Edmonton, Alberta, T6G 1Z2, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 243936
Toronto, Ontario, M5G 2M9, Canada
The Chaim Sheba Medical Center /ID# 254884
Ramat Gan, Tel Aviv, 5265601, Israel
Hadassah Medical Center-Hebrew University /ID# 254885
Jerusalem, 91120, Israel
Seoul National University Hospital /ID# 263945
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center /ID# 263220
Seoul, Seoul Teugbyeolsi, 05505, South Korea
Samsung Medical Center /ID# 263294
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Hospital Universitario Marques de Valdecilla /ID# 262826
Santander, Cantabria, 39008, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 265198
Madrid, 28040, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 23, 2022
Study Start
April 26, 2023
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share