Clinical trial NCT05512390: 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)
Official title: A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Keywords: Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Cancer
B-Cell Malignancies
ABBV-319
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-08-23
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Number of Dose-Limiting Toxicities (DLT)
timeFrame: Day 42
measure: Number of Participants with Adverse Events (AE)
timeFrame: Up to 30 Months
measure: Maximum Observed Serum Concentration (Cmax) of ABBV-319
timeFrame: Up to 6 Months
measure: Time to Cmax (Tmax) of ABBV-319
timeFrame: Up to 6 Months
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
timeFrame: Up to 6 Months
measure: Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
timeFrame: Up to 6 Months
measure: Antidrug Antibody (ADA)
timeFrame: Up to 6 Months
Secondary outcomes:
measure: Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
timeFrame: Up to 6 Months
measure: Duration of Response (DOR)
timeFrame: Up to 6 Months
measure: Time to Response
timeFrame: Up to 6 Months
measure: Progression Free Survival (PFS) Time
timeFrame: Up to 30 Months
measure: Overall survival (OS) Time
timeFrame: Up to 30 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center - Tucson /ID# 247752
state: Arizona
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
state: Florida
city: Minneapolis
country: United States
facility: Allina Health System /ID# 251782
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center /ID# 246715
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
state: New York
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center /ID# 246719
state: North Carolina
city: Dallas
country: United States
facility: Baylor Sammons Cancer Center /ID# 247715
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
state: Texas
city: Concord
country: Australia
facility: Concord Repatriation General Hospital /ID# 249240
state: New South Wales
city: Fitzroy Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 247624
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research Pty Ltd /ID# 248392
state: Western Australia
city: Edmonton
country: Canada
facility: Cross Cancer Institute /ID# 246717
state: Alberta
city: Toronto
country: Canada
facility: University Health Network_Princess Margaret Cancer Centre /ID# 243936
state: Ontario
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 254884
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Hebrew University /ID# 254885
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 263945
state: Seoul Teugbyeolsi
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: