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KN5501 Cell Injection for Refractory SLE(CLEAR)

NCT07358988 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Ruitherapeutics Co., LTD

    lead INDUSTRY

Principal Investigators

  • Mengtao Li · Rheumatology Department, Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358988 on ClinicalTrials.gov