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 patients (single-arm). The study population comprises patients with progressive forms of MS, not responsive to highly effective therapies. Upon confirmation of study eligibility, patients will receive fludarabine and cyclophosphamide (types of chemotherapy, used here for lymphodepletion) over 1 to 3 days in preparation for receiving a single obe-cel infusion. Patients will be checked closely in the 28 days following obe-cel treatment. After this, patients 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