Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
This study is testing a new treatment called obe-cel for severe lupus that affects the kidneys, known as lupus nephritis. It's for teenagers and adults aged 12 to 65 whose existing treatments haven't been effective. The main goal is to find out if obe-cel can completely clear up the signs of lupus nephritis (achieve remission) six months after treatment. Researchers will also check for other benefits like how long the remission lasts, how active their lupus is, and improvements in quality of life for up to two years. They will also look at how safe obe-cel is and how long it stays in the body.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is investigating a new treatment called obe-cel for a serious condition called systemic lupus erythematosus (SLE), specifically when it affects the kidneys, known as lupus nephritis (LN). Lupus is a long-term illness where your immune system, which normally fights off infections, mistakenly attacks your own body tissues. This can lead to inflammation and damage in various organs, and in lupus nephritis, it specifically targets the kidneys.
For many people with severe lupus nephritis, standard treatments don't always work as well as hoped. This study is for those individuals where their current treatments haven't been successful. Obe-cel is designed to target and remove certain immune cells (called B cells) that are thought to play a key role in making lupus worse. By removing these harmful cells, the hope is to reduce the inflammation and damage in the kidneys and ultimately achieve a state where the disease signs completely disappear, known as remission.
The main aim of this study is to see if obe-cel can lead to complete remission of kidney lupus after six months. Researchers will also be carefully monitoring participants for up to two years to understand how this treatment affects their lupus activity, how their quality of life changes, and how safe the treatment is overall.
النقاط الرئيسية
- This study is for a new treatment for severe kidney lupus that hasn't responded to other medicines.
- It aims to see if the treatment, obe-cel, can make kidney lupus go into remission.
- Participants will be carefully monitored for up to 2 years.
- The study includes teenagers and adults aged 12 to 65.
- It's important to understand both the possible benefits and any risks involved.
من قد يكون مؤهلاً؟
To be part of this study, you need to be between 12 and 65 years old. You must have been diagnosed with systemic lupus erythematosus (SLE) and specifically have severe active lupus nephritis, meaning your kidneys are significantly affected by the lupus. Importantly, your lupus must be considered 'refractory', which means that several standard treatments, including certain strong anti-inflammatory medicines and B cell-targeting therapies, haven't worked well enough for you.
There are also some reasons why you might not be able to join. For example, if you've already had a specific type of treatment for lupus called anti-CD19 therapy. You would also not be able to join if you have serious, lasting damage to your organs from lupus that doctors think would prevent the treatment from helping. Certain other health conditions, ongoing serious infections, a recent history of cancer, or organ transplants would also prevent participation.
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.
- Are you between 12 and 65 years old?
- Do you have a diagnosis of systemic lupus erythematosus (SLE)?
- Is your lupus affecting your kidneys severely (lupus nephritis)?
- Have your current lupus treatments not worked well enough?
- Have you *not* had a treatment called anti-CD19 therapy before?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, there are a few stages. First, there's a 'screening period' of about a month where doctors will check if you meet all the requirements. If you do, you'll enter the 'treatment period'. This involves some preparation work, where you'll receive medication to help the obe-cel treatment work better. Then, on 'Day 1' of the treatment period, you'll receive a single infusion of the obe-cel treatment.
After getting the obe-cel infusion, you'll enter the 'post-treatment period', which is all about careful follow-up. You'll have regular hospital visits for various tests, blood samples, and checks to see how you're feeling and how your lupus is responding. The main goal is to check for remission at 6 months, but you will continue to be monitored for your health and the treatment's effects for up to 2 years after your treatment.
المخاطر والفوائد المحتملة
المواقع (16)
- كلية إيكان للطب في جبل سيناءالرمز البريدي المؤكدنيويورك، الولايات المتحدة· التوظيف
- State University of New York Upstate Medical Center (SUNY)الرمز البريدي المؤكدسيراكيوز، الولايات المتحدة· التوظيف
- Texas Children's Hospitalالرمز البريدي المؤكدهيوستن، الولايات المتحدة· التوظيف
- Texas Transplant Instituteالرمز البريدي المؤكدسان أنطونيو، الولايات المتحدة· التوظيف
- Instituto D´Or de Pesquisa e Ensino - Hospital São Rafaelالرمز البريدي المؤكدSalvador, Brazil· التوظيف
- University General Hospital ATTIKONالرمز البريدي المؤكدأثينا، اليونان· التوظيف
- University General Hospital of Patrasالرمز البريدي المؤكدPátrai, Greece· التوظيف
- Queen Elizabeth Hospital Birminghamالرمز البريدي المؤكدبرمنغهام، المملكة المتحدة· التوظيف
- مركز بريستول لأمراض الدم والأورامالرمز البريدي المؤكدبريستول، المملكة المتحدة· التوظيف
- مستشفى أدينبروكالرمز البريدي المؤكدكامبريدج، المملكة المتحدة· التوظيف
- Western General Hospital Edinburghالرمز البريدي المؤكدإدنبرة، المملكة المتحدة· التوظيف
- Queen Elizabeth University Hospitalالرمز البريدي المؤكدغلاسكو، المملكة المتحدة· التوظيف
أسئلة شائعة
What is obe-cel?
Obe-cel is a new type of treatment being tested for severe lupus that targets specific immune cells to help reduce disease activity.
What is lupus nephritis?
Lupus nephritis is when lupus, an immune system disease, causes inflammation and damage to your kidneys.
من يمكنه الانضمام إلى هذه الدراسة؟
This study is for people aged 12-65 with severe lupus nephritis that hasn't responded well to standard treatments.
ما هي المدة التي سأكون مشاركًا فيها في الدراسة؟
The study involves a screening period, a treatment period, and then a follow-up period that lasts up to 2 years after treatment.
What if I want to stop participating?
يمكنك الانسحاب من الدراسة في أي وقت ولأي سبب دون أن يؤثر ذلك على رعايتك الطبية.
كيفية معرفة المزيد
Autolus Ltd
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
مدعوم من منتدانا في community.patient.info. يرجى التحلي بالاحترام — هذه ليست نصيحة طبية.