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

NCT06943937 | Recruiting Phase 1

• 1 other identifier: YTS109-005
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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

Lupus Nephritis (LN); Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  1. Dose-limiting toxicity (DLT); 2. Types, severity, and frequency of adverse events (AEs).

  28 days for DLT during the treatment assessment period, and observation AEs will be conducted up to 52 weeks post-treatment.

Secondary Outcomes (6)

• Efficacy Evaluation in LN

  The complete renal response (CRR) rate at week 12 in LN, and observation will be conducted up to 52 weeks post-treatment.

• Efficacy Evaluation in SLE-ITP

  The proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP, and observation will be conducted up to 52 weeks post-treatment.

• Peak Plasma Concentration (Cmax) of YTS109

  These detections will be conducted up to 52 weeks post-treatment.

• Time to Peak (Tmax) of YTS109

  These detections will be conducted up to 52 weeks post-treatment.

• Area under the plasma concentration versus time curve (AUC) of YTS109

  These detections will be conducted up to 52 weeks post-treatment.

Study Arms (1)

YTS109 cell

EXPERIMENTAL

Subjects will receive YTS109 cell (1E6 STAR+T cell/kg or 2E6 STAR+T cell/kg) once in this study.

Drug: YTS109 cell injection

Interventions

YTS109 cell injection DRUG

Subjects will receive YTS109 Cell Injection(1E6 STAR+T cell/kg or 2E6 STAR+T cell/kg) once in this study.

YTS109 cell

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Immunotech (Beijing) Biotechnology Co., Ltd.: lead

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis; Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Jing Pan

CONTACT

010-63290612; panj@gobroaddhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 25, 2025
• Study Start: April 16, 2025
• Primary Completion: April 25, 2026
• Study Completion (Estimated): April 25, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)