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Purpose

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 recommended Phase 2 dose (RP2D) of ABBV-319 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 114 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 recommended 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. - Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - 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. - Know active infection or clinically significant uncontrolled conditions as per the protocol.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 recommended Phase 2 dose (RP2D) is determined.
  • Drug: ABBV-319
    Intravenous (IV); Infusion
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

Recruiting Locations

University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas 78229

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.