Actively Recruiting
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-02
18
Participants Needed
1
Research Sites
177 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
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
A Clinical Study of YTS109 Cell for R/R Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years, any gender
- Adequate bone marrow function: neutrophils ≥1×10⁹/L, hemoglobin ≥60 g/L
- Liver function: ALT/AST ≤3× upper limit of normal, total bilirubin ≤1.5× upper limit of normal
- Kidney function: creatinine clearance ≥30 mL/min
- Coagulation: INR/PT ≤1.5× upper limit of normal
- Cardiovascular stability
- Fertile participants must use approved contraception or abstain during and 12 months after treatment; fertile females must have a negative serum HCG test within 7 days before enrollment and not be breastfeeding
- Voluntary participation with signed informed consent
- For relapsing/refractory SLE: meet 2019 EULAR/ACR criteria; refractory lupus nephritis or SLE-ITP as defined by treatment failure and lab/pathology criteria
- For relapsing/refractory Sjogren's syndrome: meet 2002 AECG or 2016 ACR/EULAR criteria, ESSDAI score ≥6, positive anti-SSA/Ro antibodies, persistent or recurrent disease despite conventional treatment
- For relapsing/refractory systemic sclerosis: meet 2013 ACR criteria, positive systemic sclerosis antibodies, diffuse skin sclerosis or active lung disease, persistent or progressive disease despite treatment
- For relapsing/refractory inflammatory myopathy: meet 2017 EULAR/ACR criteria, positive myositis-specific antibodies, defined muscle involvement or lung disease, persistent or progressive disease despite treatment
- For relapsing/refractory ANCA-associated vasculitis: meet 2022 ACR/EULAR criteria, positive MPO-ANCA or PR3-ANCA, BVAS score ≥15, persistent or recurrent disease despite treatment
- For relapsing/refractory antiphospholipid syndrome: meet 2006 Sydney criteria, positive antibodies at moderate to high titers, recurrent thrombosis despite standard anticoagulation or catastrophic APS criteria
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Active or suspected uncontrolled infections including fungal, bacterial, or viral
- Central nervous system diseases except certain exclusions
- Cardiac function insufficient for study interventions
- Congenital immunoglobulin deficiencies
- History of malignant tumors within last 5 years
- End-stage renal failure
- Positive for hepatitis B with high HBV DNA, hepatitis C, HIV, or syphilis infections
- Symptomatic deep vein thrombosis or pulmonary embolism within 6 months before screening
- Psychiatric disorders or severe cognitive dysfunction
- Participation in other clinical trials within 3 months before enrollment
- Recent use of immunosuppressive or biological agents within specified half-lives prior to enrollment
- Pregnant or planning pregnancy
- Other reasons judged by investigator to exclude participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Z
Zhili Wu
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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