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
the CD19 targeted CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell Leukemia and Lymphoma. Otherwise, some studies have shown that the use of CD19-targeted CAR-T therapy in refractory SLE can improve the autoimmune symptoms of patients, and at the same time, immunosuppressants and hormones can be stopped to maintain long-term autoimmune indicators normal.To verify the safety and efficacy, the investigators launch such a clinical trial using CD19 targeted CAR-T cells for patients with Refractory Autoimmune Disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
A single infusion of CD19 CAR-T cells will be administered intravenously
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
RECRUITINGIncidence 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)
Time frame: 1 month
Obtain the maximum tolerated dose of CD19 CAR-T cells[Safety and Tolerability]
Dose-limiting toxicity after cell infusion
Time frame: 1month
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)
Time frame: 3 months
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
Time frame: 3 months
Efficacy of CAR-T cell preparations in Refractory Sjogren's syndrome [Effectiveness]
The efficacy is assessed by Change value of modified Rondan skin score(mRSS) at 3M; The evaluator palpated 17 areas of the patient's body. The skin thickness of each area was calculated on a scale of 0 to 3 points. The total score was 51 points, 0 was normal skin with fine lines and no skin thickening. 1 is divided into mild skin thickening, the inspector can easily use two fingers to pinch the skin to form wrinkles, skin fine lines can also exist; 2: moderate skin thickening, more difficult to pinch the skin to form wrinkles, skin fine lines disappear; 3 is classified as severe skin thickening, unable to pinch the skin to form wrinkles.
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Time frame: 3 months
Efficacy of CAR-T cell preparations in Refractory dermatomyositis [Effectiveness]
The efficacy is assessed by CSM Total Improvement Score (TIS) 20/40/60 improvement rate at 3M;3M CSM Total Improvement Score (TIS) 20/40/60 Improvement rate: defined as the proportion of patients with a TIS score of 20-40,40-60, and ≥60 at 3M posttransfusion
Time frame: 3 months
Efficacy of CAR-T cell preparations in Refractory The antineutrophil cytoplasmic antibody-associated vasculitides [Effectiveness]
The efficacy is assessed by response rate at 3M; Defined as the percentage of patients whose BVAS score decreased to 0 at 3M after reinfusion in the absence of glucocorticoids and other therapeutic agents
Time frame: 3 months
AUCS of CD19 CAR-T cells [Cell dynamics]
AUCS is defined as the area under the curve in 90 days
Time frame: 3 months
CMAX of CD19 CAR-T cells [Cell dynamics]
CMAX is defined as the highest concentration of CD70 CAR-T cells expanded in peripheral blood
Time frame: 3 months
TMAX of CD19 CAR-T cells[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Time frame: 3 months
Pharmacodynamics of CD19 CAR-T cells[Cell dynamics]
Pharmacodynamics is defined as the degree of B cell clearance at each time point
Time frame: 3 months
Immunogenicity after infusion of CD19 CAR-T
Positive rate of anti-CAR antibody in peripheral blood
Time frame: 2 years
Immunological reconstitution of CAR-T after infusion of CD19 CAR-T
The change curve of B cells in peripheral blood after transfusion;
Time frame: 2 years