Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CD19 CAR-T cells · 2 trials · 2 indications
Types, frequency and severity of adverse events.
Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K) is from 0 to 105 points. The higher score means the stronger disease activity.
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scales. "0" indicates no disease activity and "3" indicates the most severe disease activity.
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is classified as A, B, C and D respectively. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is not involved.
The definition of SRI-4 response: SLEDAI-2K ≥ 4-Point improvement; PGA with no worsening (\<0.3 point increase); BILAG 2004 with no new A domain score and no more than 1 new B domain scores.
The definition of LLDAS: SLEDAI-2K ≤ 4 and no disease activity in major organs (kidneys, central nervous system, heart and lungs), and no vasculitis or fever; no new disease activity symptoms were added compared with previous disease assessments; PGA ≤ 1; irrespective of serology; with permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
The definition of DORIS: SLEDAI-2K = 0 ; PGA \< 0.5 ; irrespective of serology; with permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
The incidence and severity of Cytokine Release Syndrome (CRS)
The incidence and severity of Immune Effector Cell-Associated Neurotoxicity Syndrome(ICANS)
Proportions of subjects achieving Autoimmune Diseases response
| Arm | Type | Description |
|---|---|---|
| CAR-T treatment group | EXPERIMENTAL | This trial was designed as an open, single-arm, single-center, dose-increasing trial. |
| Experimental :CD19 CAR | EXPERIMENTAL | Following the lymphodepleting treatment, patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose. |
| Name | Type | Description |
|---|---|---|
| CD19 CAR-T cells | BIOLOGICAL | Three dose groups (1.5×10\^5/kg, 5×10\^5/kg, 10×10\^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. |
Inclusion Criteria: * Age ≥ 18 years old; * Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria, and still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod), and/or hydroxychlor...
CD19 CAR-T cells are being studied for the treatment of systemic lupus erythematosus and other autoimmune diseases. The therapy is in Phase 1 clinical development and is intended for patients with refractory autoimmune conditions, including those who have not responded to standard treatments.
CD19 CAR-T cells target the CD19 protein, which is expressed on B cells. By engineering a patient's T cells to recognize CD19, the therapy aims to deplete B cells that contribute to autoimmune disease pathology, potentially resetting the immune system in conditions like systemic lupus erythematosus.
CD19 CAR-T cells are being developed by Precision BioSciences, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol DTIL on the NASDAQ exchange.
CD19 CAR-T cells are currently in Phase 1 clinical trials. The therapy is investigational and has not been approved by regulatory authorities. It is being evaluated for safety and preliminary efficacy in patients with autoimmune diseases, including systemic lupus erythematosus.
CD19 CAR-T cells are being studied in two Phase 1 trials. NCT07161193 is a study for refractory autoimmune diseases with 30 participants, not yet recruiting. NCT07331467 is a study for refractory systemic lupus erythematosus with 18 participants, currently recruiting. Both trials are being conducted in China.
Yes, CD19 CAR-T cells are also referred to as anti-CD19 chimeric antigen receptor T cells. The clinical trial NCT07161193 is titled 'Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases,' confirming that CD19 CAR-T cells and anti-CD19 CAR-T therapy refer to the same investigational treatment.