drugset / Trial / NCT06676631
NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus Nephritis
NaSingle-groupOpen-labelTreatment
Summary
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.
Timeline
- Start
- 2025-02-19
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NK010 | Cell therapy | 2.5 vg | Intravenous |
| Subject | NK010 | Cell therapy | 5 vg | Intravenous |
| Subject | NK010 | Cell therapy | 7.5 vg | Intravenous |
| Subject | NK042 | Cell therapy | 1.2 vg | Intravenous |
| Subject | NK042 | Cell therapy | 2.4 vg | Intravenous |
| Subject | NK042 | Cell therapy | 6 vg | Intravenous |
| Background | Rituximab | Monoclonal antibody | 1 g | Intravenous |