Tests CAR-T cell treatment in adults with hard-to-treat nerve autoimmune diseases
Tests CAR-T immune cell therapy in adults with refractory nervous system autoimmune diseases.
Plain-language title generated from the registry record
Registry title: Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06485232, who can take part
Where in China
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xuanwu Hospital, Beijing
- Trial code
- NCT06485232
- Record updated
- 1 January 2025
- Original description
This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.Read full original descriptionShow less
An Exploratory Study on the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 in the Treatment of Refractory Autoimmune Diseases of the Nervous System
This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.
Inclusion: Aged 18-75 years (for MS patients, 18-55 years); both genders eligible; Subjects with refractory neurological autoimmune diseases who have failed standard treatment or lack effective treatment, Including neuromyelitis optica spectrum disorders(NMOSD), generalized myasthenia gravis(gMG), chronic inflammatory demyelinating Polyradiculoneuropathy(CIDP) and multiple sclerosis(MS); Anticipated survival of ≥ 12 weeks as judged by the researcher; Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication; Provides written informed consent.
Exclusion: History of solid organ transplantation; Malignant tumor within the last two years; Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis; Severe cardiac disease; History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal; Allergic constitution or a history of severe allergies; Primary immunodeficiency (congenital or acquired); Pregnant or breastfeeding women.