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

NCT06943937 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-05-13

No results posted yet for this study

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)

Interventions

DRUG

YTS109 cell injection

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

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2026-04-25
Completion
2027-04-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06943937 on ClinicalTrials.gov