NCT07358988

KN5501 Cell Injection for Refractory SLE(CLEAR)

A Multicenter Phase I Clinical Study of CD19-Targeted CAR-NK Cell Therapy for Moderate to Severe Active Systemic Lupus Erythematosus in China

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Ruitherapeutics Co., LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE). It will also learn if KN5501 cell injection works to treat refractory SLE. The main questions it aims to answer are: 1. Is KN5501 cell injection safe in adults with SLE? And the maximum tolerated dose? 2. Does KN5501 cell injection lower the disease activity of SLE in adults with refractory SLE？ Participants will: Receive one or multiple (3 to 5 times) intravenous infusion of KN5501 cell injection at inpatient ward after lymphodepletion. Visit the clinic at predefined frequency (from 1 week interval to 12-16 weeks' interval) for checkups and tests.

Conditions

• Systemic Lupus Erthematosus (SLE)

Interventions

Type	Name	Description
DRUG	KN5501 cell injection	In Part 1(SAD), six different doses will be explored to establish maximum tolerated dose for single-dose setting; In part 2(MAD and expansion), about 2-4 multiple-dose dosing regimen will be explored, and cohorts of 1-2 dosing regimen will be selected to expand.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

6 sites across 1 country: China