RecruitingInterventionalPhase 1

A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

NCT ID: NCT05512390Sponsor: AbbVieLast updated: 2026-01-16

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.

Arms & interventions

DrugABBV-319
Intravenous (IV); Infusion

Outcome measures

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).
Time frame: Day 42
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.
Time frame: Up to 30 Months
Maximum Observed Serum Concentration (Cmax) of ABBV-319
Maximum observed serum concentration of ABBV-319.
Time frame: Up to 6 Months
Time to Cmax (Tmax) of ABBV-319
Time to Cmax of ABBV-319.
Time frame: Up to 6 Months
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Terminal phase elimination half-life of ABBV-319.
Time frame: 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.
Time frame: Up to 6 Months
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Time frame: Up to 6 Months

Secondary

Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Time frame: Up to 6 Months
Duration of Response (DOR)
Time frame: Up to 6 Months
Time to Response
Time frame: Up to 6 Months
Progression Free Survival (PFS) Time
Time frame: Up to 30 Months
Overall survival (OS) Time
Time frame: Up to 30 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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. * 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 locations (8)

University of Arizona Cancer Center - Tucson /ID# 247752

Tucson, Arizona, 85724

Recruiting

Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232

Miami, Florida, 33136

Completed

Allina Health System /ID# 251782

Minneapolis, Minnesota, 55407-1321

Recruiting

University of Nebraska Medical Center /ID# 246715

Omaha, Nebraska, 68198

Recruiting

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246

New York, New York, 10065-6007

Recruiting

Novant Health Presbyterian Medical Center /ID# 246719

Charlotte, North Carolina, 28204

Recruiting

Baylor Sammons Cancer Center /ID# 247715

Dallas, Texas, 75246

Recruiting

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

San Antonio, Texas, 78229

Recruiting