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.
Plain-language title generated from the registry record
Registry title: Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Key facts
- Where
- Barcelona and Valencia, SpainSee the 2 sites
- Phase
- Phase 1
Could this be for you?
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?
Source: NCT07139743, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario Y Politecnico La FeValencia, SpainTaking people
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?
Trial details
- Who runs it
- Autolus Limited
- Trial code
- NCT07139743EU 2024-519552-93-00
- Record updated
- 16 October 2026
- Original description
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
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
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.
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.
Inclusion: 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.
Exclusion: 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.