Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

Part of paid clinical trials in Redwood City, California.

Sponsor
Autolus Limited
Study ID
NCT07139743
Phase
PHASE1
Status
Recruiting

Conditions

  • Progressive Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 4, 2025
Status verified
Mar 2026
Primary completion
Aug 15, 2029
Completion
Aug 15, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Obecabtagene autoleucel (obe-cel)

Primary Outcome Measure

Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs)) [ Time Frame: Up to Day 28 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94063
Jeffrey Dunn (PRINCIPAL_INVESTIGATOR)

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