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 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.
• 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.