This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
≥18 years old, male or female;
Systemic Lupus Erythematosus (SLE), EULAR/ACR 2019 standard;
Sjogren's Syndrome (SS), 2016 ACR/EULAR standard;
Systemic Scleroderma (SSc), 2013 ACR/EULAR Standards;
Had previously received CAR T cell therapy;
patients with serious heart, liver, lung, blood system, endocrine system diseases, and the risk of participating in the trial is higher than the benefit judged by the researcher;
There is an active or uncontrollable infection that requires systemic treatment within 1 week prior to screening;
have previously received hematopoietic stem cell transplantation or solid organ transplantation (except corneal and hair transplantation), or have grade 2 or higher acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;
Single group
CD19 targeted CAR-T cells
Biological/VaccineA single infusion of CD19 CAR-T cells will be administered intravenously
Incidence of Adverse events after CD19 CAR-T cells infusion [Safety and Tolerability]
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Obtain the maximum tolerated dose of CD19 CAR-T cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Efficacy of CAR-T cell preparations in Refractory systemic lupus erythematosus [Effectiveness]
The efficacy is assessed by SRI-4 response rate at 3M，SRI-4 response rate at 3M means Percentage of patients who met all three of the following conditions at 3M after refusion: 1. The SLEDAI-2K rating dropped by at least 4 points 2. No deterioration in PGA scores on a 3-point scale (deterioration is defined as an increase of ≥0.3 points from baseline score) 3. No new manifestations of organ system involvement (new system involvement is defined as one or more new symptoms of BILAG grade A or two or more symptoms of BILAG B)
Efficacy of CAR-T cell preparations in Refractory Systemic scleroderma [Effectiveness]
The efficacy is assessed by Change value of The EULAR Sjögren's syndrome disease activity index（ESSDAI）score at 3M
AUCS of CD19 CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 90 days
CMAX of CD19 CAR-T cells [Cell dynamics]
CMAX is defined as the highest concentration of CD70 CAR-T cells expanded in peripheral blood
TMAX of CD19 CAR-T cells[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Pharmacodynamics of CD19 CAR-T cells[Cell dynamics]
Pharmacodynamics is defined as the degree of B cell clearance at each time point
Refractory systemic lupus erythematosus -specific secondary study endpoint [Effectiveness]
SLEDAI-2K change curve within 2 years after the transfusion or subjects withdrew from the study for various reasons (whichever happened first);
Refractory Systemic scleroderma-specific secondary study endpoint [Effectiveness]
ESSDAI change curve within 2 years after transfusion or subjects withdrew from the study for various reasons (whichever happened first); ESSPRI change curve;
Refractory Sjogren's syndrome-specific secondary study endpoint [Effectiveness]
DLCO change curve within 2 years after transfusion or subjects withdrew from the study for various reasons (whichever happened first);
Refractory dermatomyositis-specific secondary study endpoint [Effectiveness]
3M CDASI score changes (Appendix 14); CDASI score change curve within 2 years after transfusion or subjects withdrew from the study for various reasons (whichever happened first);
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