Tests obe-cel cell therapy in adults with refractory progressive multiple sclerosis
Tests whether obe-cel, a modified immune cell therapy, is safe in progressive multiple sclerosis.
Key facts
- Who runs it
- Autolus Limited
- Where
- Cambridge, Edinburgh, London, and Sheffield, United KingdomSee the 4 sitesAlso in 2 other countries, 3 sites
- Trial code
- Registry title
- Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 24 people, planned
- Started
- 4 Aug 2025
- Expected to end
- 15 Aug 2029
- Type of study
- Interventional
- Treatments tested
- Obecabtagene autoleucel (obe-cel)
- Record updated
- 16 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with progressive multiple sclerosis (MS) that did not respond to at least 2 earlier MS drugs. Everyone gets the same treatment, called obe-cel.
- Age
- 18 to 60 years.
- Sex
- All sexes can join. Women cannot be pregnant or breastfeeding.
- Disease stage
- A current diagnosis of progressive MS that is refractory (did not respond to treatment). Highly active MS is not allowed.
- Earlier treatment
- Must have been treated before with at least 2 disease-modifying therapies (MS drugs that slow the disease).
Main reasons for not taking part
- Highly active multiple sclerosis
- Another autoimmune condition of the central nervous system
- Active or uncontrolled fungal, bacterial or viral infection
- Past cancer, unless disease-free for at least 24 months
- Past heart, lung, kidney or liver transplant, or stem cell transplant
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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 at least 2 disease-modifying therapies
Who cannot take part
- Any medications prohibited by the protocol
- 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
- Highly active multiple sclerosis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in United Kingdom
Also in 2 other countries, 3 sites
- Addenbrooke's HospitalCambridge, United KingdomContact: Autolus LtdTaking people
- Western General Hospital Edinburgh - PPDSE EdinburghEdinburgh, United KingdomContact: Autolus LtdTaking people
- The National Hospital for Neurology & NeurosurgeryLondon, United KingdomContact: Autolus LtdTaking people
- Royal Hallamshire HospitalSheffield, United KingdomContact: Autolus LtdTaking people
About the trial
What the trial wants to find out
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 at least 2 disease-modifying therapies.
Read full original descriptionShow less
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.
The group in the trial
- Obecabtagene autoleucel (obe-cel)Treatment being tested
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Tests obe-cel cell therapy in adults with refractory progressive multiple sclerosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07139743, who can take part
- Record updated
- 16 October 2026