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Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

Study acronym: BOBCAT
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 7 Eligibility criteria revisedv5 Show 1 more changeShow less
    • Eligibility criteria revised

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  2. Primary endpoints revised (2) Study description expanded, about 3 wordsv4 Show 1 more changeShow less
    • Study description expanded, about 3 words

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  3. Primary endpoints revised (2) Study description shortened, about 1 wordv3 Show 1 more changeShow less
    • Study description shortened, about 1 word

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  4. Secondary endpoints revised (4) Site contact updatedv2 Show 1 more changeShow less
    • Site contact updated

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  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07139743
Lead Sponsor Autolus Limited
Conditions Progressive Multiple Sclerosis
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov