Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

NCT07139743 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: AUTO1-MS12024-519552-93-001011413
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 7

Brief 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.

Conditions

Progressive Multiple Sclerosis

Keywords

Multiple sclerosis; Refractory multiple sclerosis; Progressive multiple sclerosis; Obecabtagene autoleucel; Obe-cel

Outcome Measures

Primary Outcomes (2)

• 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)

  To evaluate the safety of obe-cel in participants with refractory forms of progressive multiple sclerosis (PMS)

  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

  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).

  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)

  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)

  Up to Month 24

Study Arms (1)

Obecabtagene autoleucel (obe-cel)

EXPERIMENTAL

Biological: Obecabtagene autoleucel (obe-cel)

Interventions

Obecabtagene autoleucel (obe-cel) BIOLOGICAL

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

Obecabtagene autoleucel (obe-cel)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autolus Limited: lead

Study Sites (7)

Stanford University

Redwood City, California, 94063, 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

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Autolus Ltd

CONTACT

+44 (0)203 911 4385; clinicaltrials@autolus.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, single group assignment, open-label

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); US (1); ES (2)