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.
Age range
18 Years – 70 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Dose Limiting Toxicity
Timeframe: from the first dose to 2 weeks (SAD) or 4 weeks (MAD)
Number of participants with adverse events
Timeframe: from enrollment to the last assessment at 52 weeks