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New treatment option for Lupus Nephritis (LN)
Official title A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06943937
What this study is testing
What is YTS109 cell injection?
YTS109 cell injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis (ln).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- people must meet all of the following to be eligible for enrollment in this study:
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Meet the EULAR/ACR 2019 SLE Classification Criteri: Cohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after treatment...
- Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use). Hemoglobin ≥60 g/L.
- Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).
You likely can't join if
- will not be admitted to the study:
- Severe drug allergies or hypersensitivity.
- Uncontrolled/untreated infections (fungal, bacterial, viral, etc.).
- CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).
- Heart failure intolerance.
- Congenital immunoglobulin deficiency.
See the full eligibility criteria
- people must meet all of the following to be eligible for enrollment in this study:
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Meet the EULAR/ACR 2019 SLE Classification Criteri: Cohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after treatment with corticosteroids and ≥2 immunosuppressants (e.g., CTX, tacrolimus...
- Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use). Hemoglobin ≥60 g/L.
- Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).
- Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
- Coagulation: INR/PT ≤1.5×ULN.
- Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test...
- will not be admitted to the study:
- Severe drug allergies or hypersensitivity.
- Uncontrolled/untreated infections (fungal, bacterial, viral, etc.).
- CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).
- Heart failure intolerance.
- Congenital immunoglobulin deficiency.
- Malignancy within 5 years (exceptions: localized cancers with negligible metastasis risk).
- End-stage renal failure.
- people positive for: HBsAg / HBcAb with HBV DNA \> detection limit; HCV Ab + HCV RNA; HIV Ab; Syphilis test.
- Deep vein thrombosis/pulmonary embolism within 6 months pre- screening.
- Severe mental illness/cognitive impairment.
- Participation in other clinical trials within 3 months pre-screening.
- Use of immunosuppressants (within 5 half-lives) or biologics (within 4 weeks) pre-screening.
- Pregnancy/breastfeeding or planned conception.
- Other researcher-determined ineligibility.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.