Trial 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.
Sponsor: Autolus Limited
Participants: ALL
Start: 2025-08-04
Completion: 2029-08-15
Min Age: 18 Years
Max Age: 60 Years
Eligibility Criteria
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.
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.