A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
Recruiting
Phase 1
Interventional Study
Lupus Nephritis (LN)
Immune Thrombocytopenia (ITP)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd. · Industry
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About This Trial
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 advers…
Trial Locations
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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 Nephriti…
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