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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07583030 | A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases | EARLY_PHASE1 | NOT YET_RECRUITING | 44 | — | — | Apr 20, 2026 | Sep 20, 2041 | May 13, 2026 | 5 | China |
DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which has a causal relationship with the treatment and will limit the dose escalation.
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
An treatment-related adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which has a causal relationship with the treatment.
Determine the Recommended Dose regimen established through dose exploratory.
| Arm | Type | Description |
|---|---|---|
| LVIVO-TaVec400 product | EXPERIMENTAL | The dose escalation stage includes 4 dose level: DL1，DL2，DL3， DL4. |
| Name | Type | Description |
|---|---|---|
| LVIVO-TaVec400 product | BIOLOGICAL | Each subject will be given a single-dose LVIVO-TaVec400 via intravenous infusion. |
Inclusion Criteria: * Subjects voluntarily participate in clinical studies. * Age 18-65 years. * Adequate organ function at screening. * Clinical laboratory values meet criteria at screening visit. r/r SLE: * Patients meet the 2019 American College of Rheumatology/European League Against Rheumat...