Actively Recruiting
Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-02
18
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead Sponsor
T
The Affiliated Hospital of Xuzhou Medical University
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 3×10⁶ 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 The First Affiliated Hospital of Anhui Medical University.
CONDITIONS
Official Title
Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, any gender
- Adequate organ function including neutrophils ≥1×10^9/L, hemoglobin ≥60 g/L, liver enzymes ALT/AST ≤3 times upper limit of normal, total bilirubin ≤1.5 times upper limit, creatinine clearance ≥30 mL/min, coagulation INR/PT ≤1.5 times upper limit
- Hemodynamically stable cardiovascular status
- Fertile participants must use medically approved contraception or abstain during and 12 months after treatment; fertile females require a negative serum HCG test within 7 days before enrollment and must not be breastfeeding
- Voluntary participation with signed informed consent
- Disease-specific criteria for relapsed/refractory autoimmune diseases including SLE meeting 2019 EULAR/ACR criteria with refractory lupus nephritis or SLE-ITP; Sjogren's Syndrome meeting 2002 AECG or 2016 ACR/EULAR criteria with ESSDAI score ≥6 and anti-SSA/Ro positive; systemic sclerosis meeting 2013 ACR criteria with related antibodies and active disease; inflammatory myopathy meeting 2017 EULAR/ACR criteria with specific antibody and muscle or lung involvement; ANCA-associated vasculitis meeting 2022 ACR/EULAR criteria with active disease; antiphospholipid syndrome meeting 2006 Sydney criteria with antibody positivity and recurrent thrombosis
- Disease activity or progression definitions as specified for each condition
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Uncontrolled or treatable fungal, bacterial, viral, or other infections
- Central nervous system diseases excluding epilepsy, psychiatric disorders, organic brain syndromes, cerebrovascular accidents, encephalitis, or CNS vasculitis from underlying disease
- Cardiac function not tolerant to study treatment
- Congenital immunoglobulin deficiencies
- History of cancer within the past five years
- End-stage renal failure
- Positive for hepatitis B surface antigen and core antibody with high HBV DNA levels, hepatitis C antibody with HCV RNA positive, HIV antibody positive, or positive syphilis test
- Symptomatic deep vein thrombosis or pulmonary embolism within six months prior to screening
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within the past three months
- Recent use of immunosuppressive agents within five half-lives or biological agents within four weeks prior to enrollment
- Pregnant women or women planning pregnancy
- Other reasons deemed by investigators to preclude inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
2
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
Research Team
D
Dongmei Zhou
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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