drugset / Trial / NCT06469190
An Exploratory Clinical Study of Anti-CD19 CAR NK Cell (KN5501) in the Treatment of Relapsed/Refractory Immune Nephropathy
NaSingle-groupOpen-labelTreatment
Summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cell injection (KN5501) in patients with immune nephropathy. 36 patients are planned to be enrolled in the dose-escalation trial. The primary endpoints are DLT and TEAEs. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR)
Timeline
- Start
- 2024-06-21
- Primary completion
- 2026-06-20
- Completion
- 2027-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KN5501 | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Background | Fludarabine | Small molecule | 30 mg/m2 | — |
Indications
No indication recorded.