Actively Recruiting
An Exploratory Clinical Study of YTS109 Cell Therapy in Adults With Relapsed/Refractory Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2025-07-14
12
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and potential effectiveness of YTS109 cells in adults aged 18 to 65 who have relapsed or refractory autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, and several others. This exploratory clinical trial aims to better understand how well YTS109 cells work and their safety when used with a lymphodepletion regimen. The study is conducted as a single-arm, open-label trial at a single center. Participants will receive one infusion of YTS109 cells at a dose of 1.5 million cells per kilogram of body weight. The study focuses on monitoring adverse events and assessing efficacy over various time points. The treatment is designed to target and reduce B cells to help manage autoimmune responses. The trial plans to enroll approximately 6 to 12 patients. During the study, participants will be closely monitored for safety and treatment effects at intervals including 2, 4, 8, 12, 24, and up to 52 weeks after treatment. Researchers will conduct blood tests to measure the levels of YTS109 cells, biomarker changes, and immune system responses. The primary outcomes are the type, severity, and frequency of any adverse effects, along with efficacy evaluations. The total observation period extends up to one year to thoroughly assess safety and response to treatment.
CONDITIONS
Brief 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, regardless of gender
- Positive CD19 expression on peripheral blood B cells by flow cytometry
- Adequate organ function including bone marrow, liver, kidney, coagulation, and cardiovascular stability
- Fertile participants must use approved contraception during and for 12 months after treatment
- Voluntary participation with signed informed consent
- Specific disease criteria for relapsed or refractory conditions in Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy, ANCA-Associated Vasculitis, Antiphospholipid Syndrome, Rheumatoid Arthritis, and IgG4-Related Disease
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 some conditions like epilepsy or psychiatric disorders related to the underlying disease
- Cardiac function unable to tolerate study interventions
- Congenital immunoglobulin deficiencies
- History of malignant tumors within the past five years
- End-stage renal failure
- Positive for hepatitis B, hepatitis C, HIV, or syphilis with active infection markers
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within the past three months
- Recent use of immunosuppressive or biological agents within specified timeframes before enrollment
- Pregnant women or women planning pregnancy
- Other investigator-determined reasons precluding study inclusion
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 treatment day with follow-up assessments up to 52 weeks
Participants receive a single infusion of YTS109 cell therapy as treatment for relapsed/refractory autoimmune diseases.
Visits on Day 0, Days 4, 7, 10, and Weeks 2, 3, 4, then periodic follow-up visits up to Week 52
Duration - Up to 52 weeks post-treatment
Participants are monitored for adverse events, treatment efficacy, and pharmacokinetic/pharmacodynamic responses after the infusion.
Follow-up visits including assessments at Weeks 2, 4, 8, 12, and ongoing visits up to Week 52
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
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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