Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

NCT07139743 · tracked via the Priya Life Science UK tracker

Sponsor

Autolus Limited

Phase

Phase 1

Started

2025-08-04

Last updated

2026-03-23

Condition(s) studied

Progressive Multiple Sclerosis

Investigational drug(s) / intervention(s)

Obecabtagene autoleucel (obe-cel)

Obecabtagene autoleucel (obe-cel): Obecabtagene autoleucel (obe-cel) given as a single infusion.

Study 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). 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs)) — Up to Day 28
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS) — Up to end of study
To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)

Trial sites (7)

Facility	City	Region	Status
Stanford University	Redwood City	California	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

More Autolus Limited trials in the UK

A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL) Recruiting

Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN) Recruiting

A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL) Active, not recruiting

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus Active, not recruiting

Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells Enrolling by invitation

Other trials for the same condition

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07139743 on ClinicalTrials.gov ↗ ← All trials in the UK