Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07161193 | Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases | PHASE1 | NOT YET_RECRUITING | 30 | — | — | Sep 30, 2025 | Nov 18, 2027 | Sep 8, 2025 | 1 | China |
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 |
|---|---|---|
| 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 | Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose. |
Inclusion Criteria: * 1.Refractory Moderate-to-Severe Systemic lupus erythematosus (SLE) 1.1.Age 18-70 years. 1.2.Estimated life expectancy ≥ 3 months. 1.3.Documented disease history and diagnosis for ≥ 6 months prior to screening. 1.4.Participants must agree to use effective contraception througho...