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

NCT06797024 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-31

No results posted yet for this study

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.

Conditions

  • Autoimmune Diseases of the Nervous System

Interventions

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.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Dai-shi Tian, PhD · Tongji Hospital

  • Wei Wang, PhD · Tongji Hospital

  • Chuan Qin · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797024 on ClinicalTrials.gov