A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus

Recruiting now · Phase 1

Conditions studied: Lupus Nephritis (LN), Immune Thrombocytopenia (ITP)

In brief

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.

Key facts

Study ID

NCT06943937

Run by

China Immunotech (Beijing) Biotechnology Co., Ltd.

People needed

36

Starts

2025-04-16

Expected to finish

2027-04-25

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following inclusion criteria 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, MMF, cyclosporine) and/or biologics, with urine protein/creatinine ratio (UPCR ≥1.0 g/g) , and renal pathology requirement scriteria: ISN/RPS 2003 Class III/IV proliferative lupus nephritis (or combined with type V features) , with ≤50% glomerulosclerosis.
• Cohort 2: Refractory Immune Thrombocytopenia: Requires treatment failure with: Failed treatment with at least 1 course of MP shock (1g for 3 days) or high- dose glucocorticosteroids (1mg/kg/d equivalent dose of glucocorticosteroids) in combination with 1 or more immunosuppressive agents. At least 2 consecutive routine blood tests for platelets less than 50×10\^9/L and >30×10\^9/L were performed prior to enrolment. other non-SLE causes of thrombocytopenia, such as infections, myelosuppression and hypersplenism, were excluded.
• Essential Organ Function Criteria:
• 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 (within 7 days pre-enrollment) for fertile females; non-lactating.
• Voluntary participation with signed informed consent and compliance.
• Exclusions Criteria:
• Subjects who meet any of the following exclusion criteria 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.
• Subjects 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.

Where it is running

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.