Phase 1b Study of Loncastuximab Tesirine with Anti-cancer Agents in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

The primary objective of this study is to evaluate the **safety** and **anti-cancer activity** of Loncastuximab Tesirine when used in combination with other anti-cancer agents in patients with **relapsed or refractory B-cell Non-Hodgkin Lymphoma**. This is clinically relevant as it aims to determine the potential therapeutic benefits and safety profile of this combination treatment in a population with limited treatment options due to the relapsed or refractory nature of their disease.

The clinical trial involves a total of **73 participants** diagnosed with **Relapsed or Refractory B-cell Non-Hodgkin Lymphoma**. 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 criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet or physical activity. The selection process for the trial population is not explicitly described, and the sponsor has not provided information regarding the main objective of the trial or the principal inclusion criteria.

The clinical trial is designed to evaluate the safety and anti-cancer activity of **Loncastuximab Tesirine** in combination with other anti-cancer agents in patients with **relapsed or refractory B-cell Non-Hodgkin Lymphoma**. This study is a Phase 1b open-label trial, which means that both the researchers and participants know which treatment is being administered. The trial is expected to run from September 6, 2021, to January 20, 2027, providing a comprehensive evaluation period for the investigational treatment.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on specific criteria. Following successful screening, participants will enter the treatment phase, where they will receive the investigational drug in combination with other agents. Regular follow-up visits will be scheduled to monitor the participants' health, assess the treatment's efficacy, and record any adverse events. The end-of-study visit will conclude the trial, where 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 to treatment and overall health status. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's design and procedures aim to ensure the collection of robust data while prioritizing participant safety and well-being throughout the study duration.

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 this clinical trial.

The clinical trial is in Phase 3 and is scheduled to have an estimated recruitment start date of September 6, 2021, with an estimated end date of January 20, 2027. The efficacy of the investigational treatment will be assessed through a series of predefined parameters and endpoints, although specific details regarding these endpoints are not provided. The trial will likely involve systematic methods for measuring, collecting, and analyzing efficacy data, consistent with standard practices in Phase 3 trials. These methods may include the use of validated scales, laboratory tests, or patient-reported outcomes, measured at various timepoints throughout the study duration. The trial's design and execution will adhere to rigorous scientific and ethical standards to ensure the reliability and validity of the efficacy assessments.