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

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.

Study Overview

• Status: Recruiting
• Conditions: Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: ABBV-319

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Recruiting
      • Concord Repatriation General Hospital /ID# 249240
  • Victoria
    • Fitzroy Melbourne, Victoria, Australia, 3065
      • Recruiting
      • St Vincent's Hospital Melbourne /ID# 247624
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Recruiting
      • One Clinical Research Pty Ltd /ID# 248392
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Completed
      • Cross Cancer Institute /ID# 246717
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network_Princess Margaret Cancer Centre /ID# 243936
• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center-Hebrew University /ID# 254885
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • Completed
      • The Chaim Sheba Medical Center /ID# 254884
• South Korea
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital /ID# 263945
    • Seoul, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center /ID# 263220
    • Seoul, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center /ID# 263294
• Spain
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Fundacion Jimenez Diaz /ID# 265198
    • Contact: Site Coordinator; Phone Number: 34 915 50 48 00
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla /ID# 262826
• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona Cancer Center - Tucson /ID# 247752
  • Florida
    • Miami, Florida, United States, 33136
      • Completed
      • Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407-1321
      • Recruiting
      • Allina Health System /ID# 251782
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center /ID# 246715
  • New York
    • New York, New York, United States, 10065-6007
      • Recruiting
      • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Recruiting
      • Novant Health Presbyterian Medical Center /ID# 246719
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Sammons Cancer Center /ID# 247715
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants; Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.	Drug: ABBV-319; Intravenous (IV); Infusion
Experimental: (ABBV-319) Follicular Lymphoma (FL) Participants; Participants with R/R FL will receive ABBV-319 in 21-day cycles.	Drug: ABBV-319; Intravenous (IV); Infusion
Experimental: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants; Participants with R/R CLL will receive ABBV-319 in 21-day cycles.	Drug: ABBV-319; Intravenous (IV); Infusion
Experimental: Dose Escalation ABBV-319; Participants 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.	Drug: ABBV-319; Intravenous (IV); Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria	Number of participants with response of PR or better per disease-specific criteria.	Up to 6 Months
Duration of Response (DOR)	DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier.	Up to 6 Months
Time to Response	Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.	Up to 6 Months
Progression Free Survival (PFS) Time	PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier.	Up to 30 Months
Overall survival (OS) Time	OS is defined as time from first study treatment to death due to any cause.	Up to 30 Months

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; Follicular Lymphoma; Chronic Lymphocytic Leukemia; B-Cell Malignancies; Diffuse Large B-Cell Lymphoma; ABBV-319
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Lymphoma, B-Cell; Lymphoma; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Neoplasms; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular
• Other Study ID Numbers: M22-716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No