| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06056921 | Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease | PHASE1 | RECRUITING | 24 | — | — | Aug 31, 2023 | Aug 31, 2026 | Sep 28, 2023 | 1 | China |
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)
Dose-limiting toxicity after cell infusion
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)
The efficacy is assessed by Change value of The EULAR Sjögren's syndrome disease activity index(ESSDAI)score at 3M
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.
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
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
| Arm | Type | Description |
|---|---|---|
| CD19-targeted CAR-T | EXPERIMENTAL | CD19 targeted CAR-T cells treat |
| Name | Type | Description |
|---|---|---|
| CD19 targeted CAR-T cells | BIOLOGICAL | A single infusion of CD19 CAR-T cells will be administered intravenously |
Inclusion Criteria: 1. ≥18 years old, male or female; 2. diagnosed with one of the following diseases: * Systemic Lupus Erythematosus (SLE), EULAR/ACR 2019 standard; * Sjogren's Syndrome (SS), 2016 ACR/EULAR standard; * Systemic Scleroderma (SSc), 2013 ACR/EULAR Standards; * Dermatomyo...