Safety Evaluation of REGN5837 Combined with Odronextamab in Patients with Aggressive B-cell Non-Hodgkin Lymphomas

The primary objective of this clinical trial is to evaluate the safety profile of **REGN5837** in combination with **odronextamab** in participants diagnosed with aggressive **B-cell Non-Hodgkin lymphoma (B-NHL)**. This is clinically relevant as B-NHL represents a group of aggressive lymphoid malignancies, and determining the safety of new therapeutic combinations is crucial for advancing treatment options and improving patient outcomes.

The clinical trial involves a total of **46 participants** diagnosed with **B-cell Non-Hodgkins Lymphoma (B-NHL)**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected without targeting any vulnerable populations. The general health status of the participants is not specified, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The selection criteria for the trial population are not detailed in the provided data.

The clinical trial is designed to evaluate the safety of **REGN5837** in combination with odronextamab for participants diagnosed with aggressive **B-cell Non-Hodgkin's Lymphoma (B-NHL)**. This study is structured as a Phase 1 trial, employing a randomized, double-blind, and controlled methodology to ensure the reliability and validity of the results. The trial is expected to commence recruitment on October 9, 2023, and is projected to conclude by April 25, 2029, encompassing a comprehensive duration to adequately assess the investigational treatment's safety profile.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine 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 safety, collect data, and assess any adverse events. These visits are crucial for evaluating the ongoing safety and tolerability of the treatment regimen. The end-of-study visit will mark the conclusion of a participant's involvement, during which final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement will vary depending on individual response and tolerance to the treatment, but it is anticipated to span several months to allow for thorough observation and data collection. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the study investigators. The trial's design and procedures are meticulously crafted to ensure participant safety while striving to achieve the study's objectives.

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 October 9, 2023, with an anticipated end date of April 25, 2029. Although specific efficacy parameters such as primary and 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 changes in relevant clinical parameters. The schedule for measuring and collecting data is typically aligned with the trial's protocol, ensuring systematic and consistent data collection throughout the study duration. The analysis of efficacy data will be conducted using appropriate statistical methods to determine the potential therapeutic effects of the investigational product. The trial's findings will contribute to the understanding of the investigational product's efficacy profile, guiding future research and development efforts.