YTS109 cell therapy for patients with refractory lupus

An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus

This study is testing a new cell therapy called YTS109 to see if it can help adults with tough cases of lupus feel better and improve their kidney function.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06943937 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of YTS109 cells in adults aged 18-65 with refractory Lupus Nephritis and Systemic Lupus Erythematosus-Immune Thrombocytopenia. Approximately 36 participants will receive a single infusion of YTS109 cells, with the primary focus on monitoring dose-limiting toxicities and adverse events. Secondary endpoints include assessing the complete renal response rate and the proportion of patients achieving complete or partial response at 12 weeks post-treatment. The trial is conducted at Beijing GoBroad Hospital in China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with refractory Lupus Nephritis or Immune Thrombocytopenia who have not responded to standard treatments.

Not a fit: Patients with mild or non-refractory forms of lupus may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with refractory lupus, potentially improving their quality of life.

How similar studies have performed: While CAR-T cell therapy has shown promise in other autoimmune diseases, this specific application in lupus is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:

1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.
2. 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.

3\. Essential Organ Function Criteria:

1. Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).

   Hemoglobin ≥60 g/L.
2. Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL

   ≤1.5×ULN (disease-related elevations permitted).
3. Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
4. Coagulation: INR/PT ≤1.5×ULN.
5. 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.

5\. 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:

1. Severe drug allergies or hypersensitivity.
2. Uncontrolled/untreated infections (fungal, bacterial, viral, etc.).
3. CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).
4. Heart failure intolerance.
5. Congenital immunoglobulin deficiency.
6. Malignancy within 5 years (exceptions: localized cancers with negligible metastasis risk).
7. End-stage renal failure.
8. Subjects positive for: HBsAg / HBcAb with HBV DNA \> detection limit; HCV Ab + HCV RNA; HIV Ab; Syphilis test.
9. Deep vein thrombosis/pulmonary embolism within 6 months pre- screening.
10. Severe mental illness/cognitive impairment.
11. Participation in other clinical trials within 3 months pre-screening.
12. Use of immunosuppressants (within 5 half-lives) or biologics (within 4 weeks) pre-screening.
13. Pregnancy/breastfeeding or planned conception.
14. Other researcher-determined ineligibility.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Jing Pan

Conditions Lupus Nephritis; Immune Thrombocytopenia