A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy
Starting soon · Phase 1
Conditions studied: Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), Autoimmune Encephalitis, Stiff Person Syndrome
In brief
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
Key facts
- Study ID
- NCT07341828
- Run by
- Huashan Hospital
- People needed
- 15
- Starts
- 2026-02-01
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-01-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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