Actively Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2024-08-29
6
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
C
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead Sponsor
S
Shanghai Changzheng Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
CONDITIONS
Official Title
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Positive CD19 expression on peripheral blood B cells by flow cytometry
- Bone marrow function: neutrophil count 1�9/L, hemoglobin 0 g/L
- Liver function: ALT and AST 3 times upper limit of normal (ULN), total bilirubin 1.5 times ULN
- Kidney function: creatinine clearance 30 ml/min or higher
- Coagulation function: INR and prothrombin time 1.5 times ULN
- Stable heart function with good hemodynamic stability
- Use of medically approved contraception or abstinence during treatment and for 6 months after
- Negative serum HCG for women of childbearing age within 7 days before enrollment and not breastfeeding
- Willingness to participate, sign informed consent, comply with study and follow-up
- Specific disease criteria for recurrent/refractory systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome as detailed in study
- Disease activity and antibody positivity as defined for each condition
- Refractory or progressive disease despite conventional treatments over at least 6 months
You will not qualify if you...
- Severe drug allergy or allergic constitution
- Uncontrolled or untreated fungal, bacterial, viral, or other infections
- Central nervous system disorders excluding certain stable conditions
- Cardiac dysfunction
- Congenital immunoglobulin deficiency
- History of malignancy within past 5 years
- End-stage renal failure
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infections as specified
- Mental illness or severe cognitive impairment
- Participation in other clinical trials within 3 months prior
- Recent use of immunosuppressants or biologics within specified time frames
- Pregnant or planning pregnancy
- Other reasons as determined by investigators that exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
H
Huji Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here