A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHuashan Hospital

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

15 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Huashan Hospital

Lead sponsor

Shanghai AbelZeta Ltd.

Collaborator