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Clinical Trial Report

Gene Therapy Trial Report

Summary

Safety and Preliminary Efficacy of NXL-001 in Patients with Ischemic Stroke


NCTID NCT06761183 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Ischemic Stroke
Disease Ontology Term DOID:3526
Compound Name NXL-001
Sponsor Beijing Tiantan Hospital
Funder Type Other
Recruitment Status
Not yet recruiting
Enrollment Count 9
Results Posted Not Available

Therapy Information


Target Gene/Variant NeuroD1
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intracerebral
Drug Product Type Viral vector
Target Tissue/Cell Astrocyte
Delivery System Viral transduction
Vector Type AAV9
Editor Type none
Dose 1 Dose escalation with 3 levels, unknown concentrations
Dose 2
Dose 3
Dose 4
Dose 5

Study Record Dates


Current Stage Early phase1
Submit Date 2024-12-27
Completion Date 2026-12-31
Last Update 2025-01-07

Participation Criteria


Eligible Age 40 Years - 75 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 1
Locations China

Regulatory Information


Has US IND False
FDA Designations
Recent Updates

Resources/Links