Actively Recruiting
An Exploratory Clinical Study of YTS109 Cell Therapy in Adults With Refractory Systemic Lupus Erythematosus
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2025-05-13
36
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and potential benefits of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). These are serious and difficult-to-treat conditions associated with systemic lupus erythematosus (SLE), which affects multiple organs and involves persistent immune system problems. This exploratory study aims to gather early data on safety, effectiveness, and how the therapy behaves in the body in patients who have not responded to standard treatments. Participants will receive a single infusion of YTS109 cells, a universal allogeneic STAR-T cell therapy targeting CD19 to reduce B cells involved in autoimmune responses. The dose ranges from 1 million to 2 million STAR-T cells per kilogram of body weight. This is a single-arm, open-label trial conducted at one center, where all subjects receive the investigational treatment. The study will monitor patients for 52 weeks after treatment to assess safety and response. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities over the first 28 days, with continued observation for up to a year. Researchers will evaluate kidney response in LN patients and platelet response in SLE-ITP patients at 12 weeks post-treatment. Blood samples will be collected to analyze pharmacokinetics and pharmacodynamics of the YTS109 cells. Participants will provide informed consent and undergo regular assessments throughout the study period.
CONDITIONS
Brief Title
A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years, any gender
- Meet EULAR/ACR 2019 systemic lupus erythematosus classification criteria
- For refractory Lupus Nephritis: failed remission after corticosteroids and at least two immunosuppressants or biologics, urine protein/creatinine ratio ≥1.0 g/g, and specific renal pathology criteria
- For refractory Immune Thrombocytopenia: failed treatment with at least one course of methylprednisolone shock or high-dose glucocorticosteroids plus immunosuppressants, and low platelet counts on at least two consecutive tests excluding other causes
- Adequate organ function including bone marrow, liver, kidney, coagulation, and cardiovascular stability
- Fertile participants must use contraception or abstain during and 12 months after treatment; fertile females must have negative pregnancy test
- Voluntary participation with signed informed consent and compliance
You will not qualify if you...
- Severe drug allergies or hypersensitivity
- Uncontrolled or untreated infections
- Certain central nervous system disorders excluding epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis
- Heart failure intolerance
- Congenital immunoglobulin deficiency
- Malignancy within 5 years except localized low-risk cancers
- End-stage renal failure
- Positive for hepatitis B, hepatitis C, HIV, or syphilis infections
- Recent deep vein thrombosis or pulmonary embolism within 6 months
- Severe mental illness or cognitive impairment
- Participation in other clinical trials within 3 months
- Recent use of immunosuppressants or biologics within specified timeframes
- Pregnancy, breastfeeding, or planned conception
- Other investigator-determined ineligibility
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 event with active monitoring for 28 days
Participants receive a single infusion of YTS109 cell therapy to treat refractory systemic lupus erythematosus.
1 treatment visit and multiple follow-up visits up to 28 days
Duration - Up to 52 weeks
Participants are observed for safety, efficacy, and pharmacokinetic/pharmacodynamic outcomes up to 52 weeks post-treatment.
Regular follow-up visits over 52 weeks
Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
J
Jing Pan
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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