Actively Recruiting
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-02
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead Sponsor
I
Institute of Hematology & Blood Diseases Hospital, China
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), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3E6 STAR -T cells/kg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent/refractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. 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 Institute of Hematology \& Blood Diseases Hospital.
CONDITIONS
Official Title
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Adequate bone marrow function with neutrophils ≥1×10⁹/L and hemoglobin ≥60 g/L
- Liver function with ALT/AST ≤3 times upper limit of normal, total bilirubin ≤1.5 times upper limit (disease-related increases allowed)
- Kidney function with creatinine clearance ≥30 mL/min
- Coagulation tests with INR/PT ≤1.5 times upper limit
- Stable cardiovascular status
- Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and for 12 months after treatment; fertile females must have negative pregnancy test within 7 days before enrollment and not be breastfeeding
- Voluntary participation with signed informed consent
- Diagnosis of relapsing or refractory systemic lupus erythematosus meeting 2019 EULAR/ACR criteria
- Refractory lupus nephritis or SLE-ITP with specific clinical and pathological criteria
- Diagnosis of relapsing or refractory Sjogren's syndrome meeting 2002 AECG or 2016 ACR/EULAR criteria with disease activity score ≥6 and positive anti-SSA/Ro antibodies
- Diagnosis of relapsing or refractory systemic sclerosis meeting 2013 ACR criteria with positive antibodies and active disease features
- Diagnosis of relapsing or refractory inflammatory myopathy meeting 2017 EULAR/ACR criteria with specific antibody and clinical features
- Diagnosis of relapsing or refractory ANCA-associated vasculitis meeting 2022 ACR/EULAR criteria with active disease
- Diagnosis of relapsing or refractory antiphospholipid syndrome meeting 2006 Sydney criteria with positive antibodies and clinical features
You will not qualify if you...
- Severe history of drug allergies or allergic conditions
- Uncontrolled or treatable fungal, bacterial, viral, or other infections
- Central nervous system diseases except epilepsy, psychiatric disorders, organic brain syndromes, cerebrovascular accidents, encephalitis, or CNS vasculitis from underlying disease
- Cardiac function unable to tolerate study treatment
- Congenital immunoglobulin deficiencies
- History of cancer within the past 5 years
- End-stage kidney failure
- Positive for hepatitis B surface antigen and core antibody with high HBV DNA, hepatitis C antibody and RNA positive, HIV antibody positive, or positive syphilis test
- Symptomatic deep vein thrombosis or pulmonary embolism within 6 months before screening
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within the past 3 months
- Use of immunosuppressive agents with disease effects within five half-lives or biological agents within 4 weeks prior to enrollment
- Pregnant women or women planning pregnancy
- Other reasons deemed by investigator to preclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, China
Actively Recruiting
Research Team
Y
Ying 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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