NCT07412210

Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis: an Early Clinical Study

An Early Clinical Study to Evaluate the Safety and Efficacy of ES-NK Cell Injection in the Treatment of Refractory Lupus Nephritis

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, dose-escalation clinical trial. The entire trial is preliminarily expected to enroll 5 to 9 subjects. The initial plan is to explore three dose groups: 2.5×10⁷, 7.5×10⁷, and 2.5×10⁸ cells/kg, with 3 subjects in each group. During the trial, based on a comprehensive assessment by the Safety Review Committee (SRC), the dose, dosing frequency, or dosing interval may be adjusted or increased. In the dose-escalation phase, for the same dose group, one subject will be enrolled first. After obtaining at least 4 weeks of safety data, and upon the investigator's assessment confirming that the safety and tolerability risks are controllable, the second and third subjects can be enrolled. If the efficacy and safety data of the first subject in a dose group, based on the investigator's comprehensive judgment, indicate a significantly insufficient pharmacological effect, the study may proceed directly to the next dose group. Before proceeding to each subsequent dose group, the SRC must evaluate the safety and pharmacodynamic data from the previous dose group for at least 4 weeks. Enrollment for the next group can only begin after the SRC confirms that the safety and tolerability risks are controllable and that the next dose level remains appropriate. The dose escalation will be determined based on safety data, combined with pharmacodynamic and efficacy data.

Conditions

• Systemic Lupus Erythenlatosus Nephritis

Interventions

Type	Name	Description
BIOLOGICAL	AXA-NK02	Off-the-shelf NK cell products derived from human embryonic stem cells (hESCs)

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2026-02-17
• Last updated: 2026-03-02