Actively Recruiting
An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-02
18
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of YTS109 cells in adults aged 18 to 65 who have relapsed or refractory autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), SLE-associated immune thrombocytopenia (SLE-ITP), Sjogren's Syndrome, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, and Antiphospholipid Syndrome (APS). This Phase 1, open-label trial will enroll about 18 patients to study safety, effectiveness, and how the YTS109 cells behave in the body. Participants will receive a single infusion of YTS109 cells starting at a dose of 3 million STAR-T cells per kilogram of body weight. The dose will be increased gradually using a 3+3 escalation method. The study focuses on observing adverse events and evaluating treatment response over several weeks. The trial is conducted by China Immunotech (Beijing) Biotechnology Co., Ltd. at the Institute of Hematology & Blood Diseases Hospital. During the study, patients will be monitored closely with assessments at 2, 4, 8, 12, 24, and up to 52 weeks after treatment. Researchers will track the types, severity, and frequency of any adverse events, measure drug levels in the blood, evaluate immune system responses, and assess disease activity. This detailed monitoring includes laboratory tests and clinical evaluations to ensure patient safety and to understand how the therapy affects the autoimmune conditions over time.
CONDITIONS
Brief 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: neutrophils ≥1x10^9/L, 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
- Kidney function: creatinine clearance ≥30 mL/min
- Coagulation: INR/PT ≤1.5 times upper limit of normal
- Stable cardiovascular status
- Fertile participants must use approved contraception during and for 12 months after treatment; fertile females must have negative pregnancy test and not be breastfeeding
- Voluntary informed consent and compliance
- Diagnosis of relapsed/refractory autoimmune diseases meeting specific clinical and laboratory criteria for SLE, lupus nephritis, SLE-ITP, Sjogren's syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, or antiphospholipid syndrome
- Disease activity or progression despite conventional treatment for more than six months as defined per disease
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Uncontrolled or treatable infections (fungal, bacterial, viral, etc.)
- Central nervous system diseases excluding certain conditions like epilepsy or psychiatric disorders
- Cardiac function unable to tolerate study treatment
- Congenital immunoglobulin deficiencies
- History of cancer within past five years
- End-stage renal failure
- Positive hepatitis B, hepatitis C, HIV, or syphilis infection beyond specified limits
- Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within past three months
- Recent use of immunosuppressive or biological agents within defined washout periods
- Pregnant or planning pregnancy
- Any other conditions judged by investigators to prevent study 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 part of the treatment for relapsed/refractory autoimmune diseases.
1 infusion visit (in-person)
Duration - Up to 52 weeks post-treatment
Participants are monitored for safety and efficacy outcomes, including adverse events and clinical assessments, up to 52 weeks after treatment.
Multiple visits at day 0, 4, 7, 10, and weeks 2, 3, 4, 8, 12, and additional visits up to 52 weeks
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, China
Actively Recruiting
Research Team
Y
Ying 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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