Actively Recruiting
A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
Led by China Immunotech (Beijing) Biotechnology Co., Ltd. · Updated on 2025-05-13
36
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells/kg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.
CONDITIONS
Official 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 2019 EULAR/ACR criteria for Systemic Lupus Erythematosus
- For Lupus Nephritis: refractory after corticosteroids and at least two immunosuppressants, urine protein/creatinine ratio ≥1.0 g/g, and specific renal pathology criteria
- For Immune Thrombocytopenia: refractory after high-dose steroids and immunosuppressants, with platelet counts between 30 and 50 x10^9/L on at least two tests, and exclusion of other thrombocytopenia causes
- Bone marrow function with neutrophils ≥1 x10^9/L and hemoglobin ≥60 g/L
- Liver enzymes (ALT/AST) ≤3 times upper limit of normal, bilirubin ≤1.5 times upper limit
- Renal function with creatinine clearance ≥30 mL/min
- Coagulation tests INR/PT ≤1.5 times upper limit
- Hemodynamically stable cardiovascular status
- Fertile participants must use approved contraception or abstain during and 12 months after treatment
- Negative pregnancy test for fertile females within 7 days before enrollment
- Voluntary participation with signed informed consent and compliance
You will not qualify if you...
- Severe drug allergies or hypersensitivity
- Uncontrolled or untreated infections (fungal, bacterial, viral, etc.)
- Central nervous system disorders except epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis
- Heart failure intolerance
- Congenital immunoglobulin deficiency
- Cancer within past 5 years except localized low-risk cancers
- End-stage renal failure
- Positive tests for hepatitis B surface antigen or core antibody with detectable HBV DNA, hepatitis C antibody with RNA, HIV antibody, or syphilis
- Deep vein thrombosis or pulmonary embolism within 6 months before screening
- Severe mental illness or cognitive impairment
- Participation in other clinical trials within 3 months before screening
- Use of immunosuppressants within 5 half-lives or biologics within 4 weeks before screening
- Pregnancy, breastfeeding, or planned conception
- Other conditions judged by researchers to make the participant ineligible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206
Actively Recruiting
Research Team
J
Jing Pan
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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