Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Part of paid clinical trials in Redwood City, California.
- Sponsor
- Autolus Limited
- Study ID
- NCT07139743
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Progressive Multiple Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Obecabtagene autoleucel (obe-cel) — BIOLOGICALObecabtagene autoleucel (obe-cel) given as a single infusion.
Study Details
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.
Key Dates
- Start date
- Aug 4, 2025
- Status verified
- Mar 2026
- Primary completion
- Aug 15, 2029
- Completion
- Aug 15, 2029
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Obecabtagene autoleucel (obe-cel)
Primary Outcome Measure
Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs)) [ Time Frame: Up to Day 28 ]
Central Contacts
- Autolus Ltd+44 (0)203 911 4385
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University | Redwood City | California | 94063 | Jeffrey Dunn (PRINCIPAL_INVESTIGATOR) |
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