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 autoimmune diseases refractory to standard therapy
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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)/Myasthenia Gravis (MG)/Systemic Lupus Erythematosus (SLE)/ Systemic Sclerosis (SSc)/ Immune-Mediated Necrotizing Myopathy (IMNM) 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 for MS or NMOSD.
Primary outcome measure(s)
Incidence and severity of Adverse Events [Safety and Tolerability] — Throughout the first 3 months follow up period completion Incidence and severity of adverse events (AE) and serious adverse events (SAE) within three months following infusion
The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy — Throughout the first 24 months follow up period completion Based on the assessment of overall safety profile
Trial sites (1)
Facility
City
Region
Status
The Affiliated Hospital of Qingdao University
Qingdao
Qindao, Shandong
More The Affiliated Hospital of Qingdao University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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