This study is a single-arm, single-center Investigator-Initiated Trial (IIT) designed to evaluate the safety, pharmacokinetic profile, and preliminary efficacy of CD19-BCMA CAR-T cells in subjects diagnosed with connective tissue diseases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.
Dongguan Taixin Hospital
Dongguan, Guangdong, China
RECRUITINGEvaluation of Safety
Count the Incidence of adverse events
Time frame: Up to 2 years after CAR-T infusion
Effectiveness evaluation
The response rate of the responder index of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), systemic sclerosis (scleroderma SSc), Sjogren's Syndrome, polymyositis/dermatomyositis, and mixed connective tissue disease (MCTD), as well as the changes in scores compared with the baseline value
Time frame: Up to 2 years after CAR-T infusion
Pharmacokinetic parameters
The highest concentration of CAR-T cell expansion in peripheral blood after administration.
Time frame: Up to 2 years after CAR-T infusion
Pharmacodynamic parameters
The peak values of CAR-T-related cytokines, which include at least IL-6 and IFN-γ.
Time frame: Up to 2 years after CAR-T infusion
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