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.
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.
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).
Parallel
Universal BCMA CAR-T
DrugUniversal BCMA CAR-T
Universal CD19 CAR-T
DrugUniversal CD19 CAR-T
Universal BCMA CAR-T; Universal CD19 CAR-T
DrugUniversal BCMA CAR-T; Universal CD19 CAR-T
Incidence of dose-limiting toxicities(DLTs)
Incidence of dose-limiting toxicities(DLTs)
Incidence of adverse events(AEs) and severe adverse
Incidence of adverse events(AEs) and severe adverse events(SAEs).
Concentrations of UCAR-T cells
The concentration of BCMA UCAR T cells and CD19 UCAR-T cells in peripheral blood after infusion
B cell levels in peripheral blood
The change of B cell levels in peripheral blood after infusion
Changes of pathogenic antibody titers after infusion
The changes of pathogenic antibody titers in peripheral blood or cerebrospinal fluid.
NMOSD: Annualized relapse rate
ARR is defined as the number of relapses divided by the total participant-years after infusion
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Xuanwu Hospital, Beijing
Lead sponsor
Bioray Laboratories
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
