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)

NCT05512390 · tracked via the Priya Life Science Spain tracker

Sponsor

AbbVie

Phase

Phase 1

Started

2023-04-26

Last updated

2026-08-28

Condition(s) studied

Diffuse Large B-Cell LymphomaChronic Lymphocytic LeukemiaFollicular Lymphoma

Investigational drug(s) / intervention(s)

ABBV-319 →

ABBV-319: Intravenous (IV); Infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Number of Dose-Limiting Toxicities (DLT) — Day 42
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).
Number of Participants with Adverse Events (AE) — Up to 30 Months
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.
Maximum Observed Serum Concentration (Cmax) of ABBV-319 — Up to 6 Months
Maximum observed serum concentration of ABBV-319.
Time to Cmax (Tmax) of ABBV-319 — Up to 6 Months
Time to Cmax of ABBV-319.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 — Up to 6 Months
Terminal phase elimination half-life of ABBV-319.
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 — Up to 6 Months
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Antidrug Antibody (ADA) — Up to 6 Months
Incidence and concentration of anti-drug antibodies.

Trial sites (20)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05512390 on ClinicalTrials.gov ↗ ← All trials in Spain