Obe-cel for refractory progressive multiple sclerosis
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
This trial will test whether a single infusion of obe-cel, a CD19-directed CAR‑T therapy, is safe and shows early benefit in adults 18–60 with progressive MS that has not responded to prior high-efficacy treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Autolus Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, chimeric antigen receptor |
| Locations | 7 sites (Redwood City, California and 6 other locations) |
| Trial ID | NCT07139743 on ClinicalTrials.gov |
What this trial studies
This Phase 1, single-arm trial enrolls adults 18–60 with refractory progressive multiple sclerosis who have received at least two disease-modifying therapies. Participants receive short-course lymphodepleting chemotherapy for 1–3 days followed by a single infusion of obe-cel on Day 1. Patients are monitored closely for the first 28 days for acute safety signals and followed for up to 24 months for tolerability and preliminary efficacy. The primary aim is to characterize safety and tolerability, with exploratory measures to look for early clinical or imaging signs of benefit.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–60 with progressive multiple sclerosis who remain symptomatic despite at least two prior disease-modifying therapies, are not pregnant or breastfeeding, and have no active infections or disqualifying medical conditions.
Not a fit: Patients with highly active MS, other autoimmune CNS diseases, uncontrolled infections, recent malignancy, or prior organ or hematopoietic stem cell transplants are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, obe-cel could provide a new option that reduces disease activity or slows progression in patients with progressive MS who have exhausted other therapies.
How similar studies have performed: CD19-targeting antibodies have been effective in MS and early CAR‑T approaches in other refractory autoimmune diseases have shown promising signals, but CAR‑T therapy for progressive MS is largely experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Redwood City, California and 6 other locations
- Stanford University — Redwood City, California, United States (Not_yet_recruiting)
- Hospital Universitario Vall d'Hebron - PPDS — Barcelona, Spain (Active_not_recruiting)
- Hospital Universitari i Politecnic La Fe de Valencia — Valencia, Spain (Recruiting)
- Addenbrooke's Hospital — Cambridge, United Kingdom (Recruiting)
- Western General Hospital Edinburgh - PPDSE Edinburgh — Edinburgh, United Kingdom (Recruiting)
- The National Hospital for Neurology & Neurosurgery — London, United Kingdom (Recruiting)
- Royal Hallamshire Hospital — Sheffield, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Autolus Ltd
- Email: clinicaltrials@autolus.com
- Phone: +44 (0)203 911 4385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.