NCT07139743

Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

A Single-arm, Open-label, Phase I Study to Determine the Safety, Tolerability, and Preliminary Efficacy of Obe-cel in Participants With Refractory Progressive Forms of Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Autolus Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1 study to determine the safety, tolerability, and preliminary efficacy of obe-cel in participants with refractory progressive forms of multiple sclerosis. The study comprises 3 periods: Screening Period: From Day -30 to enrolment Treatment Period: From day of enrolment to End of Treatment (EOT) or Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion to enhance treatment efficacy and cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cell survival. Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1. Post treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.

Conditions

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	Obecabtagene autoleucel (obe-cel)	Obecabtagene autoleucel (obe-cel) given as a single infusion.

Timeline

• Start date: 2025-08-04
• Primary completion: 2029-08-15
• Completion: 2029-08-15
• First posted: 2025-08-24
• Last updated: 2026-03-23

Locations

7 sites across 3 countries: United States, Spain, United Kingdom

Regulatory

• FDA-regulated drug study