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)

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05512390
• Other study ID #: M22-716
• Status: Recruiting
• Phase: Phase 1
• Start date: April 26, 2023
• Est. completion date: February 7, 2027

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: February 7, 2027
• Est. primary completion date: February 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Diffuse Large B-Cell Lymphoma
• Follicular Lymphoma
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Follicular
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• ABBV-319
Intravenous (IV); Infusion

Locations

Country	Name	City	State
Australia	Concord Hospital /ID# 249240	Concord	New South Wales
Australia	St Vincent's Hospital Melbourne /ID# 247624	Fitzroy Melbourne	Victoria
Australia	One Clinical Research Pty Ltd /ID# 248392	Nedlands	Western Australia
Canada	Princess Margaret Cancer Centre /ID# 243936	Toronto	Ontario
Israel	Hadassah Medical Center-Hebrew University /ID# 254885	Jerusalem	Yerushalayim
Israel	The Chaim Sheba Medical Center /ID# 254884	Ramat Gan	Tel-Aviv
United States	Novant Health Presbyterian Medical Center /ID# 246719	Charlotte	North Carolina
United States	Baylor Sammons Cancer Center /ID# 247715	Dallas	Texas
United States	Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232	Miami	Florida
United States	Allina Health System /ID# 251782	Minneapolis	Minnesota
United States	Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246	New York	New York
United States	University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234	San Antonio	Texas
United States	University of Arizona Cancer Center - Tucson /ID# 247752	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 21
Primary	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
Primary	Maximum Observed Serum Concentration (Cmax) of ABBV-319	Maximum observed serum concentration of ABBV-319.	Up to 6 Months
Primary	Time to Cmax (Tmax) of ABBV-319	Time to Cmax of ABBV-319.	Up to 6 Months
Primary	Terminal Phase Elimination Half-Life (t1/2) of ABBV-319	Terminal phase elimination half-life of ABBV-319.	Up to 6 Months
Primary	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
Primary	Antidrug Antibody (ADA)	Incidence and concentration of anti-drug antibodies.	Up to 6 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall survival (OS) Time	OS is defined as time from first study treatment to death due to any cause.	Up to 30 Months