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Clinical Trials in the UK / NCT07139743
Recruiting Phase 1

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
2026-10-16

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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

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

Trial sites (7)

FacilityCityRegionStatus
Stanford University Palo Alto California 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
Royal Hallamshire Hospital Sheffield United Kingdom Recruiting

More Autolus Limited trials in the UK

Long-term Follow-up of Patients Treated With Genetically Modified Autologous T Cells Enrolling by invitation
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 Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL) 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

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