Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

Recruiting now · Phase 1

Conditions studied: Progressive Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT07139743

Run by

Autolus Limited

People needed

18

Starts

2025-08-04

Expected to finish

2029-08-15

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to give written informed consent for participation in the study.
• Ability and willingness to adhere to the protocol's Schedule of Activities and other requirements.
• Participants must be 18 to 60 years of age inclusive at the time of signing the informed consent form.
• A female participant is eligible to participate if she is not pregnant or breastfeeding.
• Current diagnosis of PMS.
• Must have been treated previously with 2 disease-modifying therapies.

You may not qualify if…

• Any medications prohibited by the protocol.
• Highly active multiple sclerosis.
• Diagnosis of another autoimmune central nervous system condition.
• Active or uncontrolled fungal, bacterial, viral infection.
• History of malignant neoplasms unless disease-free for at least 24 months.
• History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant.

Where it is running

• Addenbrooke's Hospital — Cambridge, United Kingdom (enrolling)
• The National Hospital for Neurology & Neurosurgery — London, United Kingdom (enrolling)
• Royal Hallamshire Hospital — Sheffield, United Kingdom (enrolling)
• Hospital Universitari i Politecnic La Fe de Valencia — Valencia, Spain (enrolling)
• Western General Hospital Edinburgh - PPDSE Edinburgh — Edinburgh, United Kingdom (enrolling)
• Hospital Universitario Vall d'Hebron - PPDS — Barcelona, Spain
• Stanford University — Redwood City, California, United States

Full record on ClinicalTrials.gov

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