Phase 1b Study of Mosunetuzumab and Glofitamab with CC-220 and CC-99282 in B-Cell Non-Hodgkin Lymphoma Patients

The primary objective of this early Phase 1b study is to evaluate the **safety** and **efficacy** of treatment with the drugs Mosunetuzumab or Glofitamab in combination with CC-220 and CC-99282 in patients diagnosed with **B-Cell Non-Hodgkin Lymphoma**. This study is clinically relevant as it aims to determine the potential therapeutic benefits and safety profile of these drug combinations, which could offer new treatment options for patients with this type of lymphoma.

The clinical trial involves a total of **78 participants** diagnosed with **Non-Hodgkin Lymphoma**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. 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, physical activity, or habits. The selection process for the trial population is not explicitly described, and no principal inclusion criteria are provided. The study aims to encompass a diverse demographic within the specified age range, ensuring a comprehensive understanding of the disease across different segments of the population.

The clinical trial is designed to evaluate the safety and efficacy of **Mosunetuzumab** or **Glofitamab** in combination with **CC-220** and **CC-99282** in patients diagnosed with **Non-Hodgkin Lymphoma**. This is a Phase 3, randomized, double-blind, controlled study. The trial is expected to commence recruitment on December 5, 2022, and is estimated to conclude by December 21, 2026. Participants will be involved in the study for the duration of the trial unless early termination criteria are met, such as adverse events or withdrawal of consent.

The sequence of study visits includes an initial screening visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. Regular follow-up visits will be scheduled to monitor the participants' response to the treatment and to assess any adverse effects. These visits will include clinical assessments, laboratory tests, and other relevant evaluations. The end-of-study visit will occur at the conclusion of the treatment period, where final assessments will be conducted to gather comprehensive data on the treatment's impact.

Participants are expected to adhere to the study protocol throughout the trial duration. Conditions that may lead to early termination from the study include significant protocol deviations, safety concerns, or voluntary withdrawal by the participant. The trial aims to provide valuable insights into the therapeutic potential of the investigational drugs in treating **Non-Hodgkin Lymphoma**.

The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.

In this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on December 5, 2022, with an estimated completion date of December 21, 2026. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The methods and tools for measuring efficacy, as well as the specific timepoints for these assessments, are not specified in the available information. The trial's focus is on gathering robust data to support the evaluation of the treatment's effectiveness, adhering to the rigorous standards expected in a Phase 3 clinical trial.