Phase 1 Study of JNJ-80948543, a T-cell Redirecting Antibody, in Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

The primary objective of this study is to evaluate the safety and tolerability of **JNJ-80948543**, a T-cell redirecting antibody, in participants diagnosed with **Non-Hodgkin Lymphoma (NHL)** and **Chronic Lymphocytic Leukemia (CLL)**. This is clinically relevant as it aims to determine the potential of JNJ-80948543 to provide a new therapeutic option for these hematological malignancies, which are characterized by the proliferation of malignant lymphocytes. Understanding the safety profile is crucial for assessing the feasibility of further clinical development and potential therapeutic application in these patient populations.

The clinical trial involves a total of **168 participants** diagnosed with **Non-Hodgkin Lymphoma (NHL)** and **Chronic Lymphocytic Leukemia (CLL)**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. Participants were selected to ensure a representative sample of the affected population, including vulnerable groups. The trial does not specify particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the main objective or specific inclusion criteria for the study.

The clinical trial is a **Phase 1** study designed to evaluate the safety and efficacy of a T-cell redirecting antibody in participants diagnosed with **Non-Hodgkin Lymphoma (NHL)** and **Chronic Lymphocytic Leukemia (CLL)**. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from the recruitment start date on September 2, 2022, to the anticipated end date on June 12, 2026.

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 into treatment groups. The trial will include multiple follow-up visits to monitor the participants' response to the treatment and to collect data on safety and efficacy. The end-of-study visit will conclude the trial for each participant, during which final assessments will be conducted.

The expected length of participant involvement in the trial will vary depending on individual response and the specific protocol requirements. However, participants are generally expected to remain in the study until the end-of-study visit unless specific conditions necessitate early termination. Such conditions may include adverse reactions, withdrawal of consent, or any other protocol-defined criteria that compromise participant safety or data integrity.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatment is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

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 September 2, 2022, with an anticipated end date of June 12, 2026. 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. The trial will likely employ standardized methods for data collection and analysis, consistent with clinical research protocols. The absence of detailed endpoints suggests that efficacy assessments may be exploratory, focusing on initial observations that could inform subsequent trial phases.