Actively Recruiting
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2025-07-14
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead Sponsor
T
The First Medical Center of Chinese PLA General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
CONDITIONS
Official Title
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Positive CD19 expression on peripheral blood B cells confirmed by flow cytometry
- Bone marrow function: neutrophils 1 x 10^9/L (within 2 weeks, no recent growth factor use), hemoglobin 60 g/L
- Liver function: ALT/AST 3 times upper limit of normal (disease-related elevations allowed), total bilirubin 1.5 times upper limit of normal (disease-related elevations allowed)
- Renal function: creatinine clearance 30 mL/min (Cockcroft-Gault formula, excluding acute declines)
- Coagulation: INR/PT 1.5 times upper limit of normal
- Cardiovascular: hemodynamically stable
- Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and 12 months after treatment; fertile females must have negative serum HCG test within 7 days pre-enrollment and be non-lactating
- Voluntary participation with signed informed consent and compliance
- Disease-specific criteria for relapsed/refractory conditions in Systemic Lupus Erythematosus, Sj�f6gren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Antiphospholipid Syndrome, Rheumatoid Arthritis, and IgG4-Related Disease as detailed in protocol
You will not qualify if you...
- Severe history of drug allergies or allergic constitution
- Active or suspected uncontrolled infections including fungal, bacterial, viral, or others
- Central nervous system diseases except epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis caused by underlying disease
- Cardiac function inadequate to tolerate study interventions
- Congenital immunoglobulin deficiencies
- History of malignant tumors within past five years
- End-stage renal failure
- Positive for hepatitis B surface antigen and core antibody with high HBV DNA titers, hepatitis C antibody with detectable HCV RNA, HIV antibody positive, or positive syphilis test
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within past three months
- Use of immunosuppressive agents with therapeutic effect within five half-lives or biological agents within four weeks prior to enrollment
- Pregnant or planning pregnancy
- Any other condition the investigator considers contraindicating participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
J
Jian Zhu
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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