Recruiting
Phase 1

Obe-cel

Sponsor:

Autolus Limited

Code:

NCT07139743

Conditions

Progressive Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Obecabtagene autoleucel (obe-cel)

Study Details

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 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.

Conditions

Progressive Multiple Sclerosis

Study ID

NCT07139743

Start date

Aug 4, 2025

Status verified date

Oct, 2026

Completion date

Aug 15, 2029

Anticipated

Primary completion date

Aug 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Obecabtagene autoleucel (obe-cel)

Interventions

Obecabtagene autoleucel (obe-cel)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Autolus Ltd

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

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

neuroimmunologyresearch@stanford.edu

More Information

Sponsor

Autolus Limited

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Autolus Limited on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.