NCT06797024

JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders

An Early Exploratory Clinical Study of the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection for the Treatment of Relapsed/Refractory Neurologic Immune Disorders

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

his study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed/refractory neurologic immune disorders. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed/refractory neurologic immune disorders.

Detailed description

This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory neurologic immune disorders. Upon enrolment, leukapheresis will be performed and patients will receive 3-5 days of fludarabine and cyclophosphamide lymphodepleting therapy followed by an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be evaluated for safety and efficacy for up to 24 months to determine if the disease is under control.

Conditions

• Autoimmune Diseases of the Nervous System

Interventions

Type	Name	Description
DRUG	JY231 Injection	JY231 injection is administered intravenously and produces autologous CAR-T cells in the patient's body some time after infusion. A total of 3 dose groups were established to conduct a 3+3 dose-escalation study. The doses were divided into two categories: non-lymphodepletion and lymphodepletion pretreatment. The three dose groups for lymphodepletion included: 2×10\^8 TU, 4×10\^8 TU, and 8×10\^8 TU. The three dose groups for non-lymphodepletion included: 2×10\^9 TU, 4×10\^9 TU, and 8×10\^9 TU. The decision to perform lymphodepletion was based on the lymphocyte count and function during the patient screening period.

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-01-28
• Last updated: 2025-05-31

Locations

1 site across 1 country: China