Actively Recruiting

Phase 1
Phase 2
Age: 3Years - 65Years
All Genders
NCT06688799

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

Led by Beijing GoBroad Hospital · Updated on 2026-03-10

18

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this study is to evaluate the safety and effi cacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases.

CONDITIONS

Official Title

Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases

Who Can Participate

Age: 3Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 3 to 65 years
  • Diagnosis of systemic lupus erythematosus meeting 2019 ACR/EULAR criteria with positive antinuclear antibody test
  • Refractory systemic lupus erythematosus or lupus nephritis with specific treatment history and disease activity
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Estimated survival of at least 90 days
  • Various specific refractory autoimmune disease diagnoses including Sjogren's Syndrome, systemic sclerosis, antiphospholipid syndrome, idiopathic inflammatory myopathy, and ANCA-associated vasculitis, each with respective age ranges and diagnostic criteria
  • Negative pregnancy test for women of childbearing potential and agreement to use effective contraception during and for 2 years post-study
  • Ability to discontinue immunosuppressive agents except hydroxychloroquine as assessed by clinician
  • Weight at least 40 kg for idiopathic inflammatory myopathy patients
Not Eligible

You will not qualify if you...

  • Intracranial hypertension or cerebral consciousness disorders requiring intervention
  • Symptomatic heart failure or severe arrhythmia with specific cardiac function criteria
  • Severe respiratory failure or uncontrolled respiratory symptoms
  • Presence of other malignant tumors
  • Diffuse intravascular coagulation
  • Uncontrolled infections including bacterial, viral, fungal, or parasitic infections
  • Uncontrolled diabetes with specified blood glucose thresholds and complications
  • Prior organ transplantation excluding bone marrow transplantation
  • Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73m2
  • Inability to continue immunosuppressive agents for 7 days or high risk of serious adverse reactions as judged by investigators

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

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China, China

Actively Recruiting

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Research Team

T

Tengyu Wang

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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