Contact SCGE




Gene Therapy Trial Report

Summary

A Study to Test How Well BI 3720931 is Tolerated and Whether it Improves Lung Function in People With Cystic Fibrosis (Lenticlairâ„¢ 1)


NCTID NCT06515002 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Cystic Fibrosis
Disease Ontology Term DOID:1485
Compound Name BI 3720931
Compound Description rSIV.F/HN-hCEF-soCFTR2
Sponsor Boehringer Ingelheim
Funder Type Industry
Recruitment Status
Active not recruiting
Enrollment Count 36 (ESTIMATED)
Results Posted Not Available

Therapy Information


Target Gene/Variant CFTR
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Functional gene replacement
Route of Administration Inhalational
Drug Product Type Viral vector
Target Tissue/Cell
Delivery System Viral transduction
Vector Type rSIV.F/HN
Editor Type none
Dose 1 Undisclosed low dose
Dose 2 Undisclosed medium dose
Dose 3 Undisclosed high dose
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2024-07-18
Completion Date 2028-07-04
Last Update 2025-11-24

Participation Criteria


Eligible Age >=18 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 10
Locations Netherlands,Italy,United Kingdom,France,Spain

Regulatory Information


Has US IND False
FDA Designations
Recent Updates Lentiviral vector was developed and optimized for lungs by the UK Respiratory Gene Therapy Consortium

Resources/Links