Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06614270

Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-29

15

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.

CONDITIONS

Official Title

Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years, male or female
  • Hemoglobin ≥60 g/L, white blood cell count ≥2.5×10⁹/L, neutrophil count ≥1.0×10⁹/L without colony-stimulating factor treatment within 2 weeks
  • Liver function: ALT ≤3× upper limit normal (ULN), AST ≤3× ULN, total bilirubin ≤1.5× ULN
  • Coagulation: INR <1.5× ULN, prothrombin time <1.5× ULN
  • Good cardiac function with stable hemodynamics
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study
  • Voluntary participation with signed informed consent and agreement to follow-up
  • Diagnosis and refractory or relapsed status as defined for each autoimmune disease subtype, including specific disease activity and treatment history criteria
Not Eligible

You will not qualify if you...

  • Other connective tissue diseases present
  • Severe involvement of heart, kidney (eGFR <15 mL/min/1.73m²), liver (ALT or AST >3× ULN, total bilirubin >1.5× ULN), lungs (FVC <50% predicted or corrected DLCO <40% predicted), or low blood counts (leukocytes <2.5×10⁹/L, neutrophils <1.0×10⁹/L, hemoglobin <60 g/L)
  • Active or chronic hepatitis B or C infection
  • Active or latent tuberculosis
  • HIV infection
  • Serious active infections requiring recent hospitalization or intravenous antibiotics
  • Primary or secondary immunodeficiency
  • IgA deficiency (<10 mg/dL) or IgG deficiency (<400 mg/dL)
  • Participation in another investigational drug trial within 3 months
  • History of malignancy within 5 years except certain skin or cervical cancers
  • Pregnancy, breastfeeding, or unwillingness to use contraception
  • Allergies to human or mouse proteins or monoclonal antibodies
  • Recent live or live attenuated vaccine administration
  • Psychiatric disorders, substance abuse, or inability to comply with study requirements
  • Other conditions deemed unsuitable by the investigator
  • Disease-specific exclusions such as localized systemic sclerosis, drug-induced myopathy, need for dialysis in vasculitis, liver cirrhosis in Sjogren's, and obstetric antiphospholipid syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the second affiliated hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310005

Actively Recruiting

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Research Team

J

Jing Xue, MD.,

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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