Status:
NOT_YET_RECRUITING
Universal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System.
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
Bioray Laboratories
Conditions:
Neuromyelitis Optica Spectrum Disorders
Myasthenia Gravis, Generalized
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
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 tre...
Eligibility Criteria
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.
- Primary immunodeficiency (congenital or acquired).
- 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.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
February 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06485232
Start Date
February 28 2025
End Date
December 31 2027
Last Update
January 1 2025
Active Locations (1)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053