Actively Recruiting
An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Adults With Relapsing/Refractory Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-04
18
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of YTS109 cells in adults aged 18 to 65 with relapsed or refractory autoimmune diseases, including Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Sjogren's Syndrome, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, and Antiphospholipid Syndrome. This phase 1, single-arm, open-label trial aims primarily to assess safety while also studying how well YTS109 cells work and their behavior in the body. About 18 patients will participate in this study conducted at Bengbu Third People's Hospital. Participants will receive a single infusion of YTS109 cells, starting at a dose of 3x10^6 STAR-T cells per kilogram, with dose escalation guided by a 3+3 principle. There are no placebo or comparator groups. The infusion is given once, and patients will be monitored closely for safety and treatment effects over several weeks. The study includes detailed follow-up periods to observe adverse events and treatment efficacy. During the study, participants will undergo evaluations at 2, 4, 8, 12, 24, and up to 52 weeks after treatment. These include assessments of adverse events, measurements of YTS109 cell levels in the blood at multiple time points, cytokine levels, and reconstitution of B cells in peripheral blood. Patients will provide informed consent and comply with study procedures, including use of contraception if applicable. The study also tracks various clinical and laboratory parameters to monitor safety and treatment response over time.
CONDITIONS
Brief Title
An Exploratory Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Adequate organ function including bone marrow, liver, kidney, coagulation, and stable cardiovascular status
- Fertile males or females must use approved contraception or abstain during and for 12 months after treatment; females must have a negative pregnancy test
- Voluntary participation with signed informed consent
- Diagnosis of relapsing/refractory autoimmune diseases such as systemic lupus erythematosus meeting established classification criteria
- Specific disease criteria including refractory lupus nephritis, SLE-associated immune thrombocytopenia, Sjogren's syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome with defined activity and treatment history
- Persistence or recurrence of disease activity despite conventional treatment for at least six months
You will not qualify if you...
- Severe history of drug allergies or allergic constitution
- Uncontrolled or treatable infections including fungal, bacterial, viral
- Central nervous system diseases excluding certain specified conditions
- Cardiac function insufficient to tolerate study interventions
- Congenital immunoglobulin deficiencies
- History of malignant tumors within past 5 years
- End-stage renal failure
- Positive for hepatitis B or C, HIV, or syphilis with active infection
- Recent history (within 6 months) of deep vein thrombosis or pulmonary embolism
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within past 3 months
- Recent use of immunosuppressive or biological agents within defined washout periods
- Pregnant or planning pregnancy
- Other reasons judged by investigator to preclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single infusion of YTS109 cells as the study treatment.
1 treatment visit (in-person)
Duration - Up to 52 weeks
Participants are monitored for efficacy and safety with visits and assessments continuing up to 52 weeks post-treatment.
Regular visits on day 0, 4, 7, 10, and weeks 2, 3, 4, 8, 12, with continued observation visits up to week 52
Trial Site Locations
Total: 1 location
1
The third people's Hospital of Bengbu
Bengbu, China
Actively Recruiting
Research Team
H
Hanwei Wang
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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