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

ConditionsLupus Nephritis (LN)Immune Thrombocytopenia (ITP)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Immunotech (Beijing) Biotechnology Co., Ltd.

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ranges from 18 to 65 years old (including threshold), regardless of gender.

Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).

Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL

Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: YTS109 cellExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

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

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

Secondary outcomes

1

Efficacy Evaluation in LN

The proportion of subjects who achieved complete renal response (CRR) at 12 weeks

Time frame
The complete renal response (CRR) rate at week 12 in LN, and observation will be conducted up to 52 weeks post-treatment.
2

Efficacy Evaluation in SLE-ITP

The proportion of subjects achieving complete response (CR) or partial response (PR) at 12 weeks

Time frame
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.
3

Peak Plasma Concentration (Cmax) of YTS109

To evaluate the metabolic characteristics of YTS109

Time frame
These detections will be conducted up to 52 weeks post-treatment.
4

Time to Peak (Tmax) of YTS109

To evaluate the metabolic characteristics of YTS109

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Immunotech (Beijing) Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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