Actively Recruiting
CAR-T Therapy for Refractory Autoimmune Diseases
Led by LiangZou · Updated on 2026-04-22
20
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19 CAR-T in the treatment of refractory autoimmune diseases.
CONDITIONS
Official Title
CAR-T Therapy for Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender, with signed informed consent
- Diagnosed with systemic lupus erythematosus, Sjogren's syndrome, systemic scleroderma, dermatomyositis, or ANCA-associated vasculitis
- Treated with at least 2 immunosuppressive agents for 3 months, or require 15mg or more glucocorticoids to maintain stable condition, or intolerant to standard treatment, or have relative contraindications
- For SLE, disease activity index (SLEDAI) of 8 or higher
- For SS, disease activity index (ESSDAI) of 14 or higher
- For SSc, modified skin score between 10 and 35 with interstitial pneumonia
- For DM, diagnosis for at least 1 year
- For ANCA-AAV, Birmingham Vasculitis Activity Score of 15 or higher and positive ANCA antibodies
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Adequate organ function including hemoglobin 60 g/L or higher, platelet count 30 x 10^9/L or higher, LVEF 55% or higher, normal ECG, eGFR 30 mL/min/1.73m2 or higher, liver enzymes (AST and ALT) within 3 times upper normal limit, total bilirubin within 2 times upper normal limit, lung diffusion capacity at least 40%, and forced vital capacity at least 50%
- Suitable for blood collection and no contraindications for cell collection
- Negative urine pregnancy test for childbearing subjects and agreement to use effective contraception during the trial and for one year after infusion
- Willingness to participate and signed informed consent
You will not qualify if you...
- Previous CAR-T cell therapy
- Severe heart, liver, lung, blood, or endocrine diseases increasing risk over benefit
- Active or uncontrolled infections requiring systemic treatment within 1 week before screening
- Previous hematopoietic stem cell or solid organ transplantation (excluding corneal or hair)
- Acute graft-versus-host disease grade 2 or higher within 2 weeks before screening
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA, hepatitis C antibody with high HCV RNA, HIV antibodies, syphilis, or CMV DNA
- Received live vaccine within 4 weeks before screening
- Positive pregnancy test
- History of malignant tumors except certain treated cancers
- Participation in other clinical trials within 3 months before screening
- Other conditions judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan No.1 Hospital
Wuhan, Hubei, China
Actively Recruiting
Research Team
L
Liang Zou, Doctor
CONTACT
X
Xiaoya Du
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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