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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06222853 | Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus | PHASE1 | ACTIVE NOT_RECRUITING | 22 | — | — | Feb 10, 2024 | Dec 30, 2026 | Feb 4, 2026 | 1 | China |
Incidence, type, and severity of adverse events. The grading of CRS and neurotoxicity follow the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells, published by ASTCT in 2019. Other AEs are graded using the NCI CTCAE 5.0.
| Arm | Type | Description |
|---|---|---|
| CAR-T treatment group | EXPERIMENTAL | This is an open-label, single-arm, multicenter, investigator-initiated study. The study will primarily evaluate the Target Dose of 1×10\^5 CAR+ cells/kg. The majority of subjects will be enrolled at this level to characterize efficacy and safety. Two exploratory dose levels-Low Dose (0.3×10\^5 CAR+ cells/kg) and High Dose (3×10\^5 CAR+ cells/kg)-are reserved for dose modification based on safety signals or preliminary efficacy data. |
| Name | Type | Description |
|---|---|---|
| anti-CD19-CAR-T cells | BIOLOGICAL | The study will primarily evaluate the Target Dose of 1×10\^5 CAR+ cells/kg. The majority of subjects will be enrolled at this level to characterize efficacy and safety. Two exploratory dose levels-Low Dose (0.3×10\^5CAR+ cells/kg) and High Dose (3×10\^5 CAR+ cells/kg)-are reserved for dose modification based on safety signals or preliminary efficacy data. |
Inclusion Criteria 1. Age: ≥5 years old. 2. Refractory SLE Diagnosis: 1. Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria. 2. Exhibit persistent moderate to severe disease activity (defined as a SLEDAI-2K score ≥ 8). 3. Demonstrated failure or to achieve target d...