A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to … (NCT07341828) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of C-CAR168 in the Treatment of Central Nervous System Autoimmune Diseases Refractory to Standard Therapy
15 participantsStarted 2026-02
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Incidence and severity of Adverse Events [Safety and Tolerability]
Timeframe: Throughout the first 3 months follow up period completion
2
The subsequent recommended dose of C-CAR168 in patients with central nervous system autoimmune diseases refractory to standard therapy
Timeframe: Throughout the first 24 months follow up period completion