Contact SCGE




Clinical Trial Report

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
Recruiting
Enrollment Count 36
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 2027-04-13
Last Update 2025-04-16

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

Resources/Links