Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Recruiting · NCT07139743 · Interventional (participants receive a specific treatment) · Lead sponsor: Autolus Limited
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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
7 locations listed across 1 US state.
- Stanford University - Redwood City, California, United States
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, 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
- Hospital Universitari i Politecnic La Fe de Valencia - Valencia, Spain