Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06943937
PHASE1

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

Sponsor: China Immunotech (Beijing) Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-04-16

Completion Date

2027-04-25

Last Updated

2025-05-13

Healthy Volunteers

No

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.

Locations (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China