Status:
RECRUITING
A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
Lead Sponsor:
China Immunotech (Beijing) Biotechnology Co., Ltd.
Conditions:
Lupus Nephritis (LN)
Immune Thrombocytopenia (ITP)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 patient...
Detailed Description
Background: Systemic lupus erythematosus (SLE) is characterized by multi-system and multi-organ involvement, recurrent flares and remissions, and the presence of numerous autoantibodies. LN and SLE-IT...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- 3\. 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.
- 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:
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
April 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 25 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06943937
Start Date
April 16 2025
End Date
April 25 2027
Last Update
May 13 2025
Active Locations (1)
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1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 102206