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Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases

NCT07490041 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-24

No results posted yet for this study

Summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.

Conditions

  • Rheumatic Diseases
  • Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)
  • Systemic Lupus Erythematosus (SLE)
  • Connective Tissue Disease-associated Interstitial Lung Disease

Interventions

BIOLOGICAL

KN5601

Multiple doses of anti-CD19/BCMA CAR-NK cells (KN5601) will be administered using dose-escalation strategy.

Sponsors & Collaborators

  • Rui Therapeutics Co., Ltd

    collaborator INDUSTRY

  • The Children's Hospital of Zhejiang University School of Medicine

    lead OTHER

Principal Investigators

  • Meiping Lu · The Children's Hospital of Zhejiang University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-19
Primary Completion
2026-12-19
Completion
2027-12-19

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 NCT07490041 on ClinicalTrials.gov