12
Participants
Start Date
September 30, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
BD114VLP, or BD114
"CRISPR/Cas9 instantaneous gene editing therapy, called BD114VLP (also BD114) which is a developing product of gene therapy from modified third-generation integrated defective lentivirus, can deliver gRNA/Cas9 ribonucleoprotein complex (RNP). It works to knock out or knock down HPV-16 E6/E7 genes integrated in HSIL cell genome resulting to lesion clearness or regression.~A single dosing BD114 injection by topical intraepithelial injection of HSIL lesion."
BD114VLP or BD114 plus Gel
"Genetic: BD114VLP or BD114 plus Gel CRISPR/Cas9 instantaneous gene editing therapy, called BD114VLP (also BD114) which is a developing product of gene therapy from modified third-generation integrated defective lentivirus, can deliver gRNA/Cas9 ribonucleoprotein complex (RNP). It works to knock out or knock down HPV-16 E6/E7 genes integrated in HSIL cell genome resulting to lesion clearness or regression.~Multiple dosing BD114 gel (BD114 injection :Gel, 1:1) topical application on HSIL, one time every other day, total 5 times (D0, D2, D4, D6, and D8) ."
RECRUITING
Obstetrics & Gynecology Hospital of Fudan University, Shanghai
Obstetrics & Gynecology Hospital of Fudan University
OTHER
Shanghai BDgene Co., Ltd.
INDUSTRY