Progressive Multiple SclerosisPhase 1BOBCATNCT07139743
Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
A Phase 1 study testing Obecabtagene autoleucel (obe-cel) in people with Progressive Multiple Sclerosis, run by Autolus Limited at 7 sites in 3 countries.
Trial 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 efficacy in MS. The trial includes only 1 group of participants (single-arm). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Progressive Multiple Sclerosis
- What is being tested?
- Obecabtagene autoleucel (obe-cel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 4 Aug 2025to 15 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 at least 2 disease-modifying therapies.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
Addenbrooke's Hospital
Cambridge
- Recruiting
Western General Hospital Edinburgh - PPDSE Edinburgh
Edinburgh
- Recruiting
The National Hospital for Neurology & Neurosurgery
London
uclh.car-ttrials@nhs.net
- Recruiting
Royal Hallamshire Hospital
Sheffield
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
- Recruiting
Hospital Universitari i Politecnic La Fe de Valencia
Valencia
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
neuroimmunologyresearch@stanford.edu
About this study
Official title: 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 participants (single-arm). The study population comprises participants with progressive forms of MS, not responsive to at least 2 disease-modifying 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.
Read the 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.
- Conditions
- Progressive Multiple Sclerosis
- Being tested
- Obecabtagene autoleucel (obe-cel)
- Keywords
- Multiple sclerosis, Refractory multiple sclerosis, Progressive multiple sclerosis, Obecabtagene autoleucel, Obe-cel
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obecabtagene autoleucel (obe-cel)Biological
Obecabtagene autoleucel (obe-cel) given as a single infusion.
| Study group | Role | What they receive |
|---|---|---|
| Obecabtagene autoleucel (obe-cel) | Experimental | Not described Receives: Biological: Obecabtagene autoleucel (obe-cel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))
Measured: Up to Day 28
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)
Measured: Up to end of study
Secondary outcomes (4)
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Expanded Disability Status Scale (EDSS) - Change from baseline in EDSS
The EDSS is based on a standardized neurological examination focussing on assessment of 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel / bladder and cerebral). The range of the EDSS includes 20 half steps from 0 to 10, with EDSS step 0 corresponding to a completely normal examination and EDSS step 10 to death due to MS.
Measured: Up to Month 24
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Timed 25-foot Walk Test (T25FWT).
Change from baseline in T25FWT
Measured: Up to Month 24
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using 9-hole Peg Test (9-HPT)
Change from baseline in 9-HPT
Measured: Up to Month 24
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Symbol Digit Modalities Test (SDMT)
Change from baseline in SDMT
Measured: Up to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start4 Aug 2025
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, single group assignment, open-label
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autolus Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139743
- Sponsor's protocol ID
- AUTO1-MS1
- Other IDs
- 2024-519552-93-00, 1011413
- Acronym
- BOBCAT
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07139743
- Acronym / sponsor ID
- BOBCAT / AUTO1-MS1
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- Multiple sclerosis, Refractory multiple sclerosis, Progressive multiple sclerosis, Obecabtagene autoleucel, Obe-cel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Autolus LimitedIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 at least 2 disease-modifying 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, single group assignment, open-label
| Arm | Type | Receives |
|---|---|---|
| Obecabtagene autoleucel (obe-cel) | Experimental | Biological: Obecabtagene autoleucel (obe-cel) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obecabtagene autoleucel (obe-cel)Obecabtagene autoleucel (obe-cel) given as a single infusion. | Biological | Obecabtagene autoleucel (obe-cel) |
Primary outcome
Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))
Time frame: Up to Day 28
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)
Time frame: Up to end of study
4 secondary outcomes
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Expanded Disability Status Scale (EDSS) - Change from baseline in EDSS
Time frame: Up to Month 24
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Timed 25-foot Walk Test (T25FWT).
Time frame: Up to Month 24
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using 9-hole Peg Test (9-HPT)
Time frame: Up to Month 24
To evaluate the preliminary efficacy of obe-cel in participants with refractory forms of PMS using Symbol Digit Modalities Test (SDMT)
Time frame: Up to Month 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Obecabtagene autoleucel (obe-cel) in people with Progressive Multiple Sclerosis, run by Autolus Limited at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom, Spain, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Autolus Ltd (+44 (0)203 911 4385, clinicaltrials@autolus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs)) (time frame: Up to Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.