AI CuratorAI-generated
Research summary · AI summary · not yet reviewedHuman studyPhase 1Trial registry record – peer review not applicable
Phase 1 Study of Obecabtagene Autoleucel (obe-cel) in Adults with Refractory Progressive MS
This Phase 1 study aims to evaluate the safety and tolerability of a single infusion of obe-cel in adults with refractory progressive multiple sclerosis. Participants will be observed for dose-limiting toxicities and assessed for preliminary signs of efficacy over a follow-up period of up to 24 months.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
Understanding the safety profile of obe-cel could help inform future treatments for a challenging form of multiple sclerosis, potentially paving the way for more effective therapies.
What this does not prove
No results are available yet as this is a planned study, and outcomes have not been published.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
- Trial registrationObe-cel in Refractory Progressive Forms of Multiple Sclerosis ↗
Supporting passages (9)
study phaseThis 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.
study design"detailedDescription": "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.\n\nThe study comprises 3 periods:\n\nScreening 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.\n\nObe-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.\n\nPost treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation."
subjectsParticipants must be 18 to 60 years of age inclusive at the time of signing the informed consent form.
randomizedThe trial includes only 1 group of participants (single-arm).
interventionObecabtagene autoleucel (obe-cel) given as a single infusion.
primary endpoint"measure": "Percentage of participants receiving obe-cel who experience dose-limiting toxicities (DLTs))",
follow upAfter this, participants will be monitored to evaluate safety and efficacy up to 24 months.",
findingsThe main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.