Status:
RECRUITING
Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
Lead Sponsor:
Autolus Limited
Conditions:
Progressive Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 ...
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 perio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2029
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT07139743
Start Date
August 4 2025
End Date
August 15 2029
Last Update
September 4 2025
Active Locations (1)
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1
University College London Hospital (UCLH)
London, United Kingdom