RecruitingPhase 1NCT07139743

Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants With Refractory Progressive Forms of Multiple Sclerosis


Sponsor

Autolus Limited

Enrollment

18 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS. The study also plans to assess if obe-cel can show early signs of efficacy in MS. The trial includes only 1 group of participants (single-arm). The study population comprises participants with progressive forms of MS, not responsive to highly effective therapies. Upon confirmation of study eligibility, participants will receive chemotherapy (used here for lymphodepletion) over 1 to 3 days in preparation for receiving a single obe-cel infusion. Participants will be checked closely in the 28 days following obe-cel treatment. After this, participants will be monitored to evaluate safety and efficacy up to 24 months.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR-T cell therapy called obe-cel — where immune cells are engineered to attack abnormal immune cells — in people with progressive forms of multiple sclerosis (MS) that have not responded to other treatments. It is based on the idea that MS is driven by immune cells that can be targeted with this approach. **You may be eligible if...** - You are 18 to 60 years old - You have been diagnosed with a progressive form of MS (primary or secondary progressive) - You have tried at least 2 disease-modifying MS therapies without adequate benefit - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have highly active or rapidly progressing MS - You have another autoimmune central nervous system condition - You have an active or uncontrolled infection (bacterial, viral, or fungal) - You have a history of certain cancers (unless you have been cancer-free for several years) - You are taking prohibited medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALObecabtagene autoleucel (obe-cel)

Obecabtagene autoleucel (obe-cel) given as a single infusion.


Locations(7)

Stanford University

Redwood City, California, United States

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Addenbrooke's Hospital

Cambridge, United Kingdom

Western General Hospital Edinburgh - PPDSE Edinburgh

Edinburgh, United Kingdom

The National Hospital for Neurology & Neurosurgery

London, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07139743


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