Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Purpose
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.
Condition
- Progressive Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 18 Years and 60 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single-arm, single group assignment, open-label
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Obecabtagene autoleucel (obe-cel) |
|
Recruiting Locations
More Details
- NCT ID
- NCT07139743
- Status
- Recruiting
- Sponsor
- Autolus Limited
Detailed Description
This is a Phase 1 study to determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of multiple sclerosis. The study comprises 3 periods: Screening Period: From Day -30 to enrolment Treatment Period: From day of enrolment to End of Treatment (EOT) or Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion to enhance treatment efficacy and cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cell survival. Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1. Post treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.