Clinical Trial

KN5501 Cell Injection for Refractory SLE(CLEAR)

Study acronym: CLEAR
Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07358988
Lead Sponsor Ruitherapeutics Co., LTD
Conditions Systemic Lupus Erthematosus (SLE)
Enrollment 36 participants
Start Date 2026-01
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-01-22