Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, China
Actively Recruiting
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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