At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Obecabtagene autoleucel (obe-cel) (biological)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Obecabtagene autoleucel (obe-cel) — biological: Obecabtagene autoleucel (obe-cel) given as a single infusion.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at a treatment called obe-cel for people with progressive multiple sclerosis (MS) that has not responded to other treatments. Progressive MS is a form of MS where symptoms steadily get worse over time. The study is funded by Autolus Limited.
Who can take part
- You are willing and able to give written permission (consent) to take part
- You can follow the study's schedule and other requirements
- You are aged 18 to 60 when you sign the consent form
- If female, you are not pregnant or breastfeeding
- You have a current diagnosis of progressive multiple sclerosis
- You have already been treated with 2 disease-modifying therapies (medicines that change the course of MS)
Who may not be able to
- You take any medicines not allowed by the study rules
- You have a very active form of multiple sclerosis
- You have another autoimmune condition affecting the brain or spinal cord
- You have an active or uncontrolled fungal, bacterial or viral infection
- You have had cancer, unless you have been free of it for at least 24 months
- You have had a heart, lung, kidney or liver transplant, or a stem cell transplant
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 60 Years
- Who
- All
- Number of participants
- 18
- Started
- 2025-08-04
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for progressive multiple sclerosis
- • Phase1 - 18 participants
- • 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
Who can take part?
- • Ages 18 Years to 60 Years
- • Diagnosed with progressive multiple sclerosis
Where?
- • Cambridge - Addenbrooke's Hospital
- • Edinburgh - Western General Hospital Edinburgh - PPDSE Edinburgh
- • London - The National Hospital for Neurology & Neurosurgery
- • Sheffield - Royal Hallamshire Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 60 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ been treated previously with 2 disease-modifying therapies
What the study is looking for
- ✓Willing and able to give written agreement to take part 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 agreement to take part form.
- ✓A female participant is eligible to participate if she is not pregnant or breastfeeding.
- ✓Current diagnosis of PMS.
Who cannot take part
- ✗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.
See the full criteria
Where Is This Study? (4 UK sites)
Addenbrooke's Hospital
Cambridge, United Kingdom
Western General Hospital Edinburgh - PPDSE Edinburgh
Edinburgh, United Kingdom
The National Hospital for Neurology & Neurosurgery
London, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
How to Get in Touch
Autolus Ltd
Sponsor contactCONTACT