Evaluation of ABBV-319 Pharmacokinetics, Safety, and Efficacy in Adults with Relapsed/Refractory Diffuse Large B-cell Lymphoma, Follicular Lymphoma, or Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the **adverse events** and changes in disease activity associated with the intravenous administration of ABBV-319 in adult participants diagnosed with relapsed or refractory **Diffuse Large B-cell Lymphoma (DLBCL)**, **Follicular Lymphoma (FL)**, or **Chronic Lymphocytic Leukemia (CLL)**. Understanding the safety profile and therapeutic impact of ABBV-319 is clinically significant as it may offer insights into potential treatment options for these challenging B-cell malignancies. The study also aims to investigate the pharmacokinetics of ABBV-319, providing valuable data on how the drug is processed within the body, which is crucial for optimizing dosing regimens and enhancing therapeutic efficacy.

The clinical trial involves a total of **76 participants** diagnosed with **B-cell malignancies**, including **follicular lymphoma (FL)**, **chronic lymphocytic leukemia (CLL)**, and **diffuse large B-cell lymphoma (DLBCL)**. The study population comprises both male and female subjects, with an age range that includes adults and older adults. Participants were selected without targeting a vulnerable population. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective of the trial or specific inclusion criteria.

The clinical trial is designed to evaluate the **adverse events**, changes in disease activity, and pharmacokinetics of intravenously infused ABBV-319 in adult participants with relapsed or refractory **diffuse large B-cell lymphoma (DLBCL)**, **follicular lymphoma (FL)**, or **chronic lymphocytic leukemia (CLL)**. This is a Phase 1 trial, which will be conducted as a randomized, double-blind, controlled study. The estimated recruitment start date is June 30, 2025, with an anticipated end date of June 5, 2028, indicating a total trial duration of approximately three years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational product or a control. The study will include multiple follow-up visits to monitor safety, efficacy, and pharmacokinetics, with assessments conducted at regular intervals. The end-of-study visit will conclude the participant's involvement, during which final evaluations will be performed to gather comprehensive data on the investigational product's impact.

The expected length of participant involvement will vary depending on individual response and the study's progression, but it is anticipated to last throughout the trial's duration unless early termination criteria are met. Conditions that may lead to early termination from the study include significant adverse events, withdrawal of consent, or any other medical or protocol-related reasons deemed necessary by the investigators. Participants will be closely monitored to ensure their safety and the integrity of the trial data.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is provided in the available data. Consequently, a detailed description of the experimental treatment cannot be formulated based on the current dataset.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these elements cannot be provided.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also absent from the provided data. As such, no further details can be included in this description.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is June 30, 2025, with an anticipated end date of June 5, 2028. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure potential therapeutic effects. The schedule for measuring and collecting data is not specified, but it is common in such trials to have multiple timepoints throughout the study duration to monitor changes and trends. The analysis of collected data will likely involve statistical methods appropriate for early-phase trials, focusing on identifying any initial signs of efficacy that warrant further investigation in subsequent trial phases.