What is YTS109 cell therapy studying for autoimmune diseases?

YTS109 cell therapy is being studied to evaluate its safety and effectiveness in adults with relapsed or refractory autoimmune diseases, including conditions like Systemic Lupus Erythematosus and Sjogren's Syndrome. This trial is led by China Immunotech (Beijing) Biotechnology Co., Ltd. and aims to help understand how this treatment works and its impact on these diseases.

Who may be eligible for this autoimmune disease clinical trial?

Adults aged 18 to 65 with relapsed or refractory autoimmune diseases such as SLE, Sjogren's Syndrome, or systemic sclerosis may be eligible. Participants must have stable organ function and not have severe infections or certain other health conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this autoimmune disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel or other expenses are not guaranteed to be covered and may vary depending on your situation.

Actively Recruiting

Phase 1

Age: 18Years - 65Years

All Genders

ID07236801

Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell Therapy in Adults With RelapsedRefractory Autoimmune Diseases

Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2026-03-02

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of YTS109 cell therapy in adults aged 18 to 65 with relapsed or refractory autoimmune diseases such as Systemic Lupus Erythematosus SLE, including lupus nephritis and immune thrombocytopenia, Sjogrens Syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome. This phase 1, open-label trial aims primarily to assess the safety of YTS109 cells, while also studying their impact on disease symptoms and how the cells behave in the body. Participants will receive a single infusion of YTS109 cells, starting at a dose of 3 x 106 STAR-T cells per kilogram. The dose will be adjusted following a 33 escalation design to determine the best dose. This single-arm study will include approximately 18 patients who will be observed over time to monitor outcomes and any side effects. During the trial, participants will undergo assessments for safety and efficacy at 2, 4, 8, and 12 weeks after infusion, with follow-up for adverse events extending to 24 weeks and continued observation up to 52 weeks. Researchers will also measure levels of YTS109 cells and related biomarkers in the blood at multiple time points to understand how the cells are processed in the body. Participants will have laboratory tests and clinical evaluations throughout the study and follow-up period to monitor their condition and treatment effects.

CONDITIONS

Brief Title

Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Age between 18 and 65 years old, any gender
Adequate bone marrow, liver, kidney, coagulation, and cardiovascular function
Fertile participants must use approved contraception or abstain during and 12 months after treatment; females must have a negative pregnancy test
Voluntary participation with signed informed consent
Diagnosis of relapsing or refractory Systemic Lupus Erythematosus meeting 2019 EULAR/ACR criteria, including refractory lupus nephritis or immune thrombocytopenia
Diagnosis of relapsing or refractory Sjogren's Syndrome meeting 2002 AECG or 2016 ACR/EULAR criteria, with disease activity score ESSDAI ≥6 and positive anti-SSA/Ro antibodies
Diagnosis of relapsing or refractory systemic sclerosis meeting 2013 ACR criteria, with positive related antibodies and active skin or lung disease
Diagnosis of relapsing or refractory inflammatory myopathy meeting 2017 EULAR/ACR criteria, positive myositis-specific antibodies, with muscle or lung involvement
Diagnosis of relapsing or refractory ANCA-associated vasculitis meeting 2022 ACR/EULAR criteria, positive MPO-ANCA or PR3-ANCA, and active disease (BVAS ≥15)
Diagnosis of relapsing or refractory antiphospholipid syndrome meeting 2006 Sydney criteria with positive antibodies and recurrent thrombosis despite standard treatment

You will not qualify if you...

History of severe drug allergies or allergic constitution
Current or suspected uncontrolled infections including fungal, bacterial, viral
Central nervous system diseases excluding some specified 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, hepatitis C, HIV, or syphilis with viral loads above detection 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 3 months
Recent use of immunosuppressive or biological agents within specified washout periods
Pregnant or planning pregnancy
Any other reason deemed by investigator to preclude inclusion in the study

Research Team

Dongmei Zhou

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