RECRUITING Phase 1 ClinicalTrials.gov

Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

Sponsor: Autolus Limited • ClinicalTrials.gov ID: NCT07139743

Registry updated: 2026-10-16

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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. 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.

Interventions

Obecabtagene autoleucel (obe-cel) (Biological)
Obecabtagene autoleucel (obe-cel) given as a single infusion.

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 at least 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.

Conditions

Progressive Multiple Sclerosis

Locations

Stanford University — Palo Alto, California, United States
Hospital Universitario Vall d'Hebron - PPDS — Barcelona, Spain
Hospital Universitari i Politecnic La Fe de Valencia — Valencia, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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