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.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
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.
النقاط الرئيسية
- 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.
من قد يكون مؤهلاً؟
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.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Am I between 18 and 60 years old?
- Do I have a progressive form of MS?
- Have I already tried at least two other MS medications?
- Am I able to attend all study appointments and follow instructions?
- Am I pregnant or breastfeeding, or do I have an active infection or certain other serious health problems?
ماذا يتضمن المشاركة؟
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.
المخاطر والفوائد المحتملة
المواقع (7)
- جامعة ستانفوردالرمز البريدي المؤكدبالو ألتو، الولايات المتحدة· التوظيف
- Hospital Universitario Vall d'Hebron - PPDSالرمز البريدي المؤكدبرشلونة، إسبانيا· التوظيف
- Hospital Universitari i Politecnic La Fe de Valenciaالرمز البريدي المؤكدفالنسيا، إسبانيا· التوظيف
- مستشفى أدينبروكالرمز البريدي المؤكدكامبريدج، المملكة المتحدة· التوظيف
- Western General Hospital Edinburgh - PPDSE Edinburghالرمز البريدي المؤكدإدنبرة، المملكة المتحدة· التوظيف
- The National Hospital for Neurology & Neurosurgeryالرمز البريدي المؤكدلندن، المملكة المتحدة· التوظيف
- Royal Hallamshire Hospitalالرمز البريدي المؤكدشيفيلد، المملكة المتحدة· التوظيف
أسئلة شائعة
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.
كم من الوقت سأكون في الدراسة؟
After checking if you're suitable, you'll receive treatment and then be closely monitored for up to two years.
هل سيعالج هذا العلاج مرض التصلب المتعدد لدي؟
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.
هل يمكنني التوقف عن المشاركة إذا أردت؟
Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your future medical care.
كيفية معرفة المزيد
Autolus Ltd
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نقاش
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