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Obe-cel in Refractory Progressive Forms of Multiple Sclerosis

This research study is investigating a new treatment called obe-cel for adults living with progressive forms of multiple sclerosis (MS). These are people whose MS hasn't improved with other strong medications. The main goals are to carefully check if obe-cel is safe to use and if it causes any unwanted side effects. Researchers will also be looking for any early signs that the treatment might be effective in helping with MS symptoms. Participants will receive a type of chemotherapy for a few days before a single infusion of obe-cel. The study will closely follow participants for up to two years to understand both the safety and any potential benefits of this new approach.

De un vistazo

Estado
Reclutamiento
Fase
FASE1
Patrocinador
Autolus Limited
Objetivo de inscripción
24
Inicio
04 Aug 2025
Estimación de finalización
15 Aug 2029

¿De qué trata este estudio?

This study is focused on a new type of treatment called obe-cel for people who have a progressive form of Multiple Sclerosis (MS). This means their MS is steadily getting worse, and it hasn't responded well to the usual strong treatments. The main purpose of this study is to find out if obe-cel is safe and well-tolerated, meaning it doesn't cause too many problems or unpleasant side effects.

The researchers are also interested in whether obe-cel shows any early signs of being helpful for MS. This is a very early-stage study, so it's mainly about understanding safety first. If obe-cel proves safe, future studies might explore its effectiveness more deeply. This research is important because new treatments are always needed for progressive MS, especially for those whose condition hasn't improved with existing therapies.

Participants will go through a specific process. First, they'll receive a short course of chemotherapy, which in this case is used to prepare their immune system for the obe-cel treatment. A few days later, they will receive a single infusion of obe-cel. After this, they will be closely monitored for about a month, and then continue to be checked regularly for up to two years to see how they are doing with the treatment.

Puntos clave

  • This study is for adults with progressive MS that hasn't responded to other treatments.
  • It's checking the safety and early effectiveness of a new treatment called obe-cel.
  • Participants will receive a short course of chemotherapy before a single obe-cel infusion.
  • You will be closely monitored for up to two years after the treatment.
  • This is an early-stage study, so potential risks and benefits will be carefully assessed.

¿Quién puede ser elegible?

To join this study, you need to be an adult between 18 and 60 years old. You must have a current diagnosis of a progressive form of MS and have already tried at least two other strong MS medications without enough success. It's also important that you are able and willing to follow all the study's instructions and attend appointments.

There are also reasons why someone might not be able to join. For example, if you are pregnant or breastfeeding, or if you have another autoimmune condition affecting your brain and spinal cord, you wouldn't be eligible. People with active infections, certain types of cancer in the last two years, or a history of major organ transplants (like heart, lung, kidney, liver, or bone marrow) would also not be able to take part. The study also cannot accept people with very active MS, as described by certain medical criteria.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. Am I between 18 and 60 years old?
  2. Do I have a progressive form of MS?
  3. Have I already tried at least two other MS medications?
  4. Am I able to attend all study appointments and follow instructions?
  5. Am I pregnant or breastfeeding, or do I have an active infection or certain other serious health problems?
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

If you decide to take part in this study, you'll first have a 'screening period' lasting up to a month. During this time, doctors will do tests and checks to make sure the study is suitable for you. If you qualify, you'll then enter a 'treatment period'. This involves receiving chemotherapy over 1 to 3 days, followed by a single infusion of the obe-cel treatment on a specific day, referred to as Day 1. The chemotherapy is used to prepare your body for the obe-cel, not to treat cancer.

After receiving obe-cel, you will be very closely monitored for the first 28 days. Following this initial period, you'll continue to have regular check-ups and assessments by the study team, who will monitor your health, look for any side effects, and see how your MS is doing. This follow-up will continue for up to 24 months (two years). During this time, you'll need to attend all scheduled appointments and follow the study's instructions.

Riesgos y beneficios potenciales

Taking part in this study may offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help with your progressive MS. However, as with any new treatment, there are potential risks and possible side effects, some of which might be serious, especially from the chemotherapy and the obe-cel infusion. The study aims to carefully monitor these. It's very important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Ubicaciones (7)

  • Stanford University
    Código postal verificado
    Palo Alto, Estados Unidos· Reclutamiento
  • Hospital Universitario Vall d'Hebron - PPDS
    Código postal verificado
    Barcelona, España· Reclutamiento
  • Hospital Universitari i Politecnic La Fe de Valencia
    Código postal verificado
    Valencia, España· Reclutamiento
  • Hospital Addenbrooke
    Código postal verificado
    Cambridge, Reino Unido· Reclutamiento
  • Western General Hospital Edinburgh - PPDSE Edinburgh
    Código postal verificado
    Edimburgo, Reino Unido· Reclutamiento
  • The National Hospital for Neurology & Neurosurgery
    Código postal verificado
    Londres, Reino Unido· Reclutamiento
  • Royal Hallamshire Hospital
    Código postal verificado
    Sheffield, United Kingdom· Reclutamiento

Preguntas comunes

What is obe-cel?

Obe-cel is a new type of treatment being studied for progressive multiple sclerosis. It's still in the early stages of research.

Why do I need chemotherapy before obe-cel?

The chemotherapy used here is a low dose given for a short time to help prepare your immune system to receive and respond better to the obe-cel treatment.

¿Cuánto tiempo estaré en el estudio?

After checking if you're suitable, you'll receive treatment and then be closely monitored for up to two years.

Will this treatment cure my MS?

This is an early study focusing on safety and early signs of how well it works. It's not expected to be a cure for MS.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your future medical care.

Cómo obtener más información

Autolus Ltd

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

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