Phase I Study on Safety, Tolerability, and Efficacy of OBE-CEL in Refractory Progressive Multiple Sclerosis

The primary objective of this study is to evaluate the **safety**, **tolerability**, and preliminary **efficacy** of OBE-CEL in participants with **Refractory Progressive Multiple Sclerosis**. This is clinically relevant as it aims to address the unmet medical need in patients who have not responded to existing therapies, potentially offering a new therapeutic option for managing this debilitating condition.

The clinical trial involves a total of **15 participants** diagnosed with **Refractory Progressive Multiple Sclerosis**. The study population includes both male and female subjects, with an **age range** of 18 to 65 years. Participants were selected based on specific criteria, although the principal inclusion criteria were not provided by the sponsor. The trial does not involve a vulnerable population. General health status and lifestyle considerations such as diet, physical activity, or habits were not specified in the available data. The selection process aimed to ensure a representative sample of individuals affected by the condition under investigation.

The clinical trial is designed as a **single-arm, open-label, Phase I study** to evaluate the safety, tolerability, and preliminary efficacy of OBE-CEL in participants with **refractory progressive multiple sclerosis**. The trial is set to commence on October 1, 2025, with an estimated completion date of January 15, 2029. The study will involve a series of visits, beginning with an inclusion visit where participants will undergo screening to confirm eligibility based on predefined criteria. This initial visit will include assessments to ensure participants meet the necessary health and medical condition requirements for trial participation.

Following the inclusion visit, participants will attend scheduled follow-up visits at regular intervals. These visits are designed to monitor the participants' health, assess the safety and tolerability of the investigational product, and collect data on its preliminary efficacy. The sequence and frequency of these visits will be determined by the study protocol, ensuring comprehensive monitoring throughout the trial duration. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather data on the long-term effects of the treatment.

The expected length of participant involvement will span the entire trial duration, from the initial screening to the end-of-study visit. However, certain conditions may lead to early termination from the study, such as adverse reactions to the investigational product, withdrawal of consent, or failure to comply with study procedures. Participants will be closely monitored to ensure their safety and well-being throughout the trial. The study's design and procedures are structured to provide robust data on the investigational product's impact on refractory progressive multiple sclerosis, contributing valuable insights into its potential therapeutic benefits.

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 addition to the experimental medication, the trial may include the use of **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatments. However, the data does not provide explicit details about these treatments, including their names, dosages, or administration routes. The trial documentation does not specify any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring.

Due to the lack of detailed information in the source data, further specifics about the experimental and non-experimental treatments, including their pharmaceutical forms and administration protocols, cannot be provided. The trial documentation should be consulted for comprehensive details regarding the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on October 1, 2025, with an estimated completion date of January 15, 2029. The efficacy assessment will be conducted through a series of predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 3 trials, focusing on evaluating the treatment's effectiveness in a larger population. The trial's design will likely incorporate validated scales, laboratory tests, or patient-reported outcomes to measure efficacy, consistent with standard practices in clinical research. The absence of specific endpoints in the provided data suggests that these will be defined in the detailed trial protocol, ensuring comprehensive evaluation of the treatment's impact on the targeted medical condition.