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

NCT ID: NCT07341828

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-02-28

Brief Summary

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

Conditions

Multiple Sclerosis (MS); Neuromyelitis Optica Spectrum Disorders (NMOSD); Autoimmune Encephalitis; Stiff Person Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-CAR168

Autologous C-CAR168 administered by intravenous (IV) infusion

Group Type: EXPERIMENTAL

CD20/BCMA-directed CAR-T cells

Intervention Type: BIOLOGICAL

Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Interventions

CD20/BCMA-directed CAR-T cells

Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously

Intervention Type: BIOLOGICAL

Other Intervention Names

C-CAR168

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Severe cardiovascular diseases within the past 6 months prior to screening.
• A history of ≥ Grade 2 bleeding within 4 weeks prior to screening, or requiring long-term anticoagulants treatment.
• Inadequate washing time for previous treatment.
• Previously treated with CAR-T cell products or genetically modified T cell therapies.
• Pregnant or lactating women.
• Severe central nervous system diseases or pathological changes.
• Malignancy history within 5 years prior to signing the ICF.
• Any contraindication to lumbar puncture.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiangjun Chen

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Xiangjun Chen

Role: CONTACT

xiangjchen@fudan.edu.cn

+86 21 52888159

Other Identifiers

KY2025-1015

Identifier Type: -

Identifier Source: org_study_id