Actively Recruiting
An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing/Refractory Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-02
18
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
C
China Immunotech (Beijing) Biotechnology Co., Ltd.
Lead Sponsor
T
The First Affiliated Hospital of Anhui Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of YTS109 cells in adults aged 18 to 65 with relapsed or refractory autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and related conditions such as Lupus Nephritis (LN), SLE-associated immune thrombocytopenia, Sjogren's Syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome. This phase 1, open-label study aims mainly to evaluate safety and also to examine how well YTS109 cells work and behave in the body. Participants will receive a single infusion of YTS109 cells, starting at a dose of 3×10⁶ STAR-T cells per kilogram of body weight. The dosing will follow a 3+3 escalation design to carefully adjust the dose. There is only one treatment group in this study. The infusion is a one-time procedure during the treatment period. During the study, participants will be closely monitored through regular assessments up to 52 weeks after treatment. Safety is tracked by observing adverse events and their severity. Effectiveness is assessed at multiple time points from 2 to 52 weeks. Blood tests will measure YTS109 cell levels, cytokine changes, and B cell recovery. Participants must agree to informed consent and follow-up visits to complete all evaluations throughout the study duration.
CONDITIONS
Brief Title
A 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 old, any gender
- Adequate organ function including bone marrow, liver, kidney, coagulation, and cardiovascular stability
- Use of medically approved contraception or abstinence for fertile participants and negative pregnancy test for fertile females
- Voluntary participation with signed informed consent
- Diagnosis of relapsed/refractory systemic lupus erythematosus meeting 2019 EULAR/ACR criteria or
- Diagnosis of relapsed/refractory Sjogren's syndrome meeting 2002 AECG or 2016 ACR/EULAR criteria
- Diagnosis of relapsed/refractory systemic sclerosis meeting 2013 ACR criteria
- Diagnosis of relapsed/refractory inflammatory myopathy meeting 2017 EULAR/ACR criteria
- Diagnosis of relapsed/refractory ANCA-associated vasculitis meeting 2022 ACR/EULAR criteria
- Diagnosis of relapsed/refractory antiphospholipid syndrome meeting 2006 Sydney-revised criteria
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 and related conditions
- Cardiac function unable to tolerate study interventions
- Congenital immunoglobulin deficiencies
- History of malignant tumors within past 5 years
- End-stage renal failure
- Positive for hepatitis B with high viral load, hepatitis C, HIV, or syphilis
- 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 3 months prior to enrollment
- Recent use of immunosuppressive or biological agents within specified washout periods
- Pregnant women or women planning pregnancy
- Other reasons judged by investigator to preclude 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 the investigational treatment.
1 infusion visit (in-person)
Duration - Up to 52 weeks post-treatment
Participants are monitored for safety and efficacy through various assessments including blood tests and clinical evaluations.
Multiple visits including days 0, 4, 7, 10 and weeks 2, 3, 4, 8, 12, then ongoing assessments until week 52
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
Research Team
H
Huan Zhou
Z
Zhili Wu
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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