Tests a patient's own modified immune cells in adults with autoimmune diseases
Tests C-CAR168 cells in adults with lupus, myositis, and other autoimmune diseases.
Plain-language title generated from the registry record
Registry title: A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06249438, who can take part
Where in China
- Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- RenJi Hospital
- Trial code
- NCT06249438
- Record updated
- 25 July 2025
- Original description
This is an investigator-initiated, multicenter, 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 therapyRead full original descriptionShow less
An Exploratory Clinical Study of Cluster of Differentiation Antigen 20(CD20)/Anti-B-cell Maturation Antigen(BCMA) Chimeric Antigen Receptor Autologous T Cell Product (C-CAR168) in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
This is an investigator-initiated, multicenter, 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
Inclusion: 18 to 70 years old at the time of signing the Informed Consent Form (ICF); Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis Optica Spectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG)/Systemic Sclerosis (SSc) according to recognized diagnostic criteria for at least 6 months; Remains disease active or relapses after treatment with standard of care therapy for at least 8 weeks with the dose stable for more than 2 weeks; patients should have been treated with at least two immunosuppressants (including immunosuppressants, biologics, and disease-modifying drug (DMD) ); Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.
Exclusion: 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; ≥ Grade 2 bleeding within the past 30 days 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; Malignancy history within 5 years prior to signing the ICF; 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; Severe central nervous system diseases or pathological changes; Pregnant or lactating women.