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)

Recruiting now · Phase 1

Conditions studied: Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma

In brief

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.

Key facts

Study ID

NCT05512390

Run by

AbbVie

People needed

154

Starts

2023-04-26

Expected to finish

2027-02-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 — Madrid, Spain (enrolling)
• Samsung Medical Center /ID# 263294 — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
• Hospital Universitario Marques de Valdecilla /ID# 262826 — Santander, Cantabria, Spain (enrolling)
• University of Arizona Cancer Center - Tucson /ID# 247752 — Tucson, Arizona, United States (enrolling)
• Allina Health System /ID# 251782 — Minneapolis, Minnesota, United States (enrolling)
• University of Nebraska Medical Center /ID# 246715 — Omaha, Nebraska, United States (enrolling)
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 — New York, New York, United States (enrolling)
• Novant Health Presbyterian Medical Center /ID# 246719 — Charlotte, North Carolina, United States (enrolling)
• Baylor Sammons Cancer Center /ID# 247715 — Dallas, Texas, United States (enrolling)
• University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 — San Antonio, Texas, United States (enrolling)
• Concord Repatriation General Hospital /ID# 249240 — Concord, New South Wales, Australia (enrolling)
• St Vincent's Hospital Melbourne /ID# 247624 — Fitzroy Melbourne, Victoria, Australia (enrolling)
• One Clinical Research Pty Ltd /ID# 248392 — Nedlands, Western Australia, Australia (enrolling)
• University Health Network_Princess Margaret Cancer Centre /ID# 243936 — Toronto, Ontario, Canada (enrolling)
• Hadassah Medical Center-Hebrew University /ID# 254885 — Jerusalem, Israel (enrolling)
• Seoul National University Hospital /ID# 263945 — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
• Asan Medical Center /ID# 263220 — Seoul, Seoul Teugbyeolsi, South Korea (enrolling)
• Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 — Miami, Florida, United States
• The Chaim Sheba Medical Center /ID# 254884 — Ramat Gan, Tel Aviv, Israel
• Cross Cancer Institute /ID# 246717 — Edmonton, Alberta, Canada

Full record on ClinicalTrials.gov

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