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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Autologous 2nd generation CD20/BCMA-directed CAR-T cells, single infusion intravenously
Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of Adverse Events [Safety and Tolerability]
Incidence of any adverse events (AEs), including dose limiting toxicities (DLTs)
Time frame: Throughout the first 24 months follow up period completion (3 years)，DLTs will be observed/collected throughout the 28 days post C-CAR168 infusion
The subsequent recommended dose of C-CAR168 in patients with autoimmune diseases refractory to standard therapy
Based on the assessment of dose-limiting toxicities (DLTs) rates and overall safety profile
Time frame: Throughout the first 24 months follow up period completion (3 years)
The proportion of subjects who achieved remission at 6 months (6M)
Time frame: Throughout the first 6 months follow up period completion (1.5 years)
The proportion of subjects who achieved remission during the main study period
Time frame: Throughout the first 24 months follow up period completion (3 years)
The proportion of subjects who experienced relapse during the main study period
Time frame: Throughout the first 24 months follow up period completion (3 years)
Time to response (TTR)
The time from the date of C-CAR168 infusion to the first documented remission
Time frame: Throughout the first 24 months follow up period completion (3 years)
Progression-free survival (PFS)
The time from the date of C-CAR168 infusion to the date of first documented disease progression or death, whichever comes first
Time frame: Throughout the first 24 months follow up period completion (3 years)
The proportion of subjects who achieved glucocorticoids/immunosuppressant free and subjects who achieved low-dose glucocorticoids application during the main study period
Time frame: Throughout the first 24 months follow up period completion (3 years)
Maximal plasma concentration (Cmax)
Maximal plasma concentration of C-CAR168 in peripheral blood
Time frame: Throughout the first 24 months follow up period completion (3 years)
Time to reach the maximal plasma concentration (Tmax)
Time to reach the maximal plasma concentration of C-CAR168 in peripheral blood
Time frame: Throughout the first 24 months follow up period completion (3 years)
Duration in peripheral blood (Tlast)
The duration of C-CAR168 in peripheral blood
Time frame: Throughout the first 24 months follow up period completion (3 years)
Area under curve (AUC)
Area under the curve of C-CAR168 in peripheral blood
Time frame: Throughout the first 24 months follow up period completion (3 years)
The clearance of peripheral blood B cell
Time frame: Throughout the first 24 months follow up period completion (3 years)
The decline of serum immunoglobulin
Time frame: Throughout the first 24 months follow up period completion (3 years)
The elevation of peripheral blood complement
Time frame: Throughout the first 24 months follow up period completion (3 years)
The decline of autoantibodies or other disease specific biomarkers
Time frame: Throughout the first 24 months follow up period completion (3 years)
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