This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.
Aged 18-65 years ; both genders eligible.
Meets the criteria for Refractory NMOSD.
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.
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).
Sequential
Universal BCMA-CD19 CART
Drug1.0-4.0×10\^6 CAR-T cells/kg
DLT
The number and severity of dose-limiting toxicity (DLT) events
AEs
The total number, incidence, and severity of AEs
Annualized relapse rate (ARR)
Number of NMOSD relapses in subjects after cell infusion divided by observation time (years)
Click on the lead sponsor to view all of their trials.
Bioray Laboratories
Lead sponsor
Wenzhou Medical University Affiliated Ophthalmology Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
