Obe-cel for refractory progressive multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 at least 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 it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• Hospital Universitario Vall d'Hebron - PPDS
  Barcelona, Spain 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

Study contacts

• Study coordinator: Autolus Ltd
• Email: clinicaltrials@autolus.com
• Phone: +44 (0)203 911 4385

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.