Approval Probability
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CD19 targeted CAR-T cells · 1 trial · 5 indications
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...
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CD19 targeted CAR-T cells are an investigational cell therapy being studied for use in systemic lupus erythematosus (SLE), also known as systemic lupus. The therapy is being evaluated in a Phase 1 clinical trial for patients with refractory autoimmune diseases, including SLE and other conditions such as Sjogren's syndrome and systemic scleroderma.
CD19 targeted CAR-T cells target the CD19 protein, which is found on the surface of B cells. By engineering a patient's T cells to recognize and attack CD19-expressing cells, the therapy aims to deplete the B cells that contribute to autoimmune disease activity in conditions like systemic lupus erythematosus.
CD19 targeted CAR-T cells are being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial to evaluate the safety and efficacy of this therapy in patients with refractory autoimmune diseases.
CD19 targeted CAR-T cells are currently in Phase 1 clinical development. The therapy is investigational and has not been approved by regulatory authorities. It is being studied in an early-stage trial to assess its safety and efficacy in patients with systemic lupus erythematosus and other autoimmune conditions.
CD19 targeted CAR-T cells are being evaluated in one active Phase 1 clinical trial with the identifier NCT06056921. This trial, titled 'Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease,' is recruiting 24 participants in China and is open to adults aged 18 years and older.
CD19 targeted CAR-T cells are part of a class of CAR-T cell therapies that target the CD19 antigen, which is also the target of several approved cancer treatments. However, this specific therapy is being developed by Precision BioSciences for autoimmune indications, including systemic lupus erythematosus, rather than for cancer.