Phase 1b Evaluation of JNJ-80948543 with CD3 T-Cell Engagers in Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies

The primary objective of this study is to evaluate the safety and tolerability of **JNJ-80948543** in combination with other CD3 T-cell engagers (TCEs) in patients with **relapsed/refractory B-cell Non-Hodgkin Lymphoid Malignancies**. This is clinically relevant as it aims to determine the potential of this combination therapy to provide a new treatment option for patients who have not responded to or have relapsed after standard therapies. The study focuses on assessing adverse events, dose-limiting toxicities, and establishing a recommended dose for further clinical trials.

The clinical trial involves a total of **24 participants** diagnosed with **relapsed/refractory B-cell non-Hodgkin lymphoid malignancies**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected to include a vulnerable population, although specific selection criteria are not provided. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The sponsor has not disclosed detailed inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the safety and efficacy of JNJ-80948543 in combination with other CD3 T-cell engagers (TCEs) for patients with **relapsed/refractory B-cell Non-Hodgkin Lymphoid Malignancies**. This study is a Phase 1b trial, characterized by a randomized, double-blind, and controlled design, ensuring that neither the participants nor the researchers know which treatment the participants are receiving, thus minimizing bias. The trial is expected to commence recruitment on December 9, 2024, and is projected to conclude by September 21, 2026, indicating an overall duration of approximately 21 months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria will be assessed. This visit is crucial for determining the suitability of participants for the trial. Following successful inclusion, participants will attend regular follow-up visits, which are scheduled to monitor the safety and efficacy of the treatment regimen. These visits will include assessments such as physical examinations, laboratory tests, and imaging studies as necessary. The end-of-study visit will mark the conclusion of the participant's involvement, where final evaluations will be conducted to gather comprehensive data on the treatment outcomes.

The expected length of participant involvement will vary depending on individual response to treatment and the specific protocol requirements. However, participants are generally expected to remain in the study for the entire duration unless specific conditions necessitate early termination. Such conditions may include adverse reactions to the treatment, withdrawal of consent, or any other medical or ethical reasons deemed significant by the study investigators. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in the study.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 9, 2024, with an estimated completion date of September 21, 2026. The efficacy assessment will be conducted using predefined primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate measurement and analysis of efficacy parameters. The study will adhere to rigorous standards typical of Phase 3 trials, ensuring that the data collected is robust and reliable for evaluating the treatment's effectiveness. The trial's design and execution will be aligned with clinical best practices to provide meaningful insights into the treatment's impact on the targeted medical condition.