NCT06243159

JY231(Internal Clinical Drug Code) Injection for the Treatment of Refractory Autoimmune Diseases

JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanxi Bethune Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases

Detailed description

This is a single-center, single-arm. open-treatment clinical study, in this study. approximately 10-20 adult and elderly patients with refractory autoimmune diseases will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects\' own previous standard treatment regimens or base data.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
GENETIC	JY231	Infusion of JY231 Injection by dose of 1-10×10\^6 TU/kg、 1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-02-06
• Last updated: 2024-02-06

Locations

1 site across 1 country: China