Actively Recruiting
CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases
Led by Zhejiang University · Updated on 2024-04-09
45
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for Autoimmune Diseases.
CONDITIONS
Official Title
CD19-BAFF CAR-T Cells Therapy for Patients With Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gender unlimited, age over 18 years
- Diagnosed with Autoimmune Diseases (Systemic Lupus Erythematosus, Immune nephritis, Systemic sclerosis, Dermatomyositis, Neuromyelitis optica) and after routine treatment with more than 2 types of drugs is ineffective for more than 6 months or disease activity reappears or no effective treatment after remission
- Estimated life expectancy of at least 12 weeks
- Blood tests showing lymphocyte count > 0.3 x 10^9/L
- Blood tests showing neutrophils 0.5 x 10^9/L
- Blood tests showing hemoglobin 60 g/L
- Blood tests showing platelet count 30 x 10^9/L
- Pregnant or lactating women, or patients with fertility willing to use effective contraception for at least 6 months after last cell infusion during study
- Voluntary participation with informed consent
You will not qualify if you...
- History of brain injury, consciousness disorders, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Electrocardiogram showing prolonged QT interval or severe heart diseases such as severe arrhythmia
- Pregnant or lactating women
- Patients with HIV infection
- Active hepatitis B or hepatitis C infection
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Creatinine > 176.8 umol/L, ALT/AST > 3 times normal, or bilirubin > 51 umol/L
- Any condition deemed unsuitable by investigator
- Received CAR-T, CAR-NK, or gene modified cell therapy within 3 months
- Received immunosuppressive therapy within 1 week before mononuclear cell collection
- Used systemic steroids exceeding 20 mg/day prednisone or equivalent within 1 week before treatment (excluding recent or current inhaled steroids)
- Any condition that may increase risk or interfere with trial results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, 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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