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

NCT06614270 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-29

No results posted yet for this study

Summary

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

  • Systemic Sclerosis (SSc)
  • ANCA Associated Vasculitis (AAV)
  • Idiopathic Inflammatory Myopathy (IIM)
  • Sjogren's Syndrome
  • Antiphospholipid Syndrome
  • Systemic Lupus Erythematosus

Interventions

DRUG

Anti-CD19 IL-10/IL15 CAR-NK

Patients will receive Fludarabine and Cyclophosphamide for conditioning. Multiple doses of Anti-CD19 IL-10/IL15 CAR-NK cells will be infused on Day 0, 3, and 6.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2026-01-06
Completion
2027-01-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06614270 on ClinicalTrials.gov