About this trial
This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with central nervous system autoimmune diseases refractory to standard therapy
Eligibility criteria
Qualifiers
18 to 70 years old at the time of signing the Informed Consent Form (ICF).
Diagnosed as Multiple Sclerosis (MS)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Autoimmune Encephalitis(AiE)/Stiff Person Spectrum Disorder(SPSD) according to recognized diagnostic criteria for at least 6 months.
Prior treatment failure with standard therapy.
Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
Disqualifiers
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive, Epstein-Barr Virus (EBV) DNA positive.
Uncontrolled active infection.
Live vaccine injection within 4 weeks prior to signing the ICF.
Major organ transplantation history or bone marrow/hematopoietic stem cell transplantation history.
Trial design
Treatments tested in this trial
- CD20/BCMA-directed CAR-T cells
Treatment groups
Locations
Sponsors and collaborators
Huashan Hospital
Lead sponsor
Shanghai AbelZeta Ltd.
Collaborator