Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease

Browse trials for

• Sjogren's Syndrome 371
• Dermatomyositis 171
• Vasculitis 230
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis 139
• Scleroderma, Systemic 688
• Scleroderma, Diffuse 528

Keywords

• CAR-T
• CD19

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 24 is below the median of 50 across 244 interventional studies indexed under Sjogren's Syndrome.

Lead sponsor

Chongqing Precision Biotech Co., Ltd is the lead sponsor of 51 studies on the registry; 37 are open to participants now.

Study arms

• Experimental
  CD19-targeted CAR-T

  CD19 targeted CAR-T cells treat

  Biological: CD19 targeted CAR-T cells

Interventions

• BiologicalCD19 targeted CAR-T cells

  A single infusion of CD19 CAR-T cells will be administered intravenously

Primary outcomes

1. 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)

   Time frame: 1 month

2. Obtain the maximum tolerated dose of CD19 CAR-T cells[Safety and Tolerability]

   Dose-limiting toxicity after cell infusion

   Time frame: 1month

3. 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

4. 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

5. 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.

   Time frame: 3 months

6. 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

7. 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

Secondary outcomes

1. AUCS of CD19 CAR-T cells [Cell dynamics]

   AUCS is defined as the area under the curve in 90 days

   Time frame: 3 months

2. 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

3. TMAX of CD19 CAR-T cells[Cell dynamics]

   TMAX is defined as the time to reach the highest concentration

   Time frame: 3 months

4. 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

5. Immunogenicity after infusion of CD19 CAR-T

   Positive rate of anti-CAR antibody in peripheral blood

   Time frame: 2 years

6. 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

Other outcomes

1. 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);

   Time frame: 2 years

2. 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;

   Time frame: 2 years

3. 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);

   Time frame: 2 years

4. 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);

   Time frame: 2 years

5. Refractory The antineutrophil cytoplasmic antibody-associated vasculitides -specific secondary study endpoint [Effectiveness]

   BVAS score within 2 years after retransfusion or when subjects withdrew from the study for various reasons (whichever occurred first).

   Time frame: 2 years