A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL

NARecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
High-grade Squamous Intraepithelial Lesions (HSIL)
Interventions
GENETIC

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."

GENETIC

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) ."

Trial Locations (1)

200090

RECRUITING

Obstetrics & Gynecology Hospital of Fudan University, Shanghai

All Listed Sponsors
collaborator

Obstetrics & Gynecology Hospital of Fudan University

OTHER

lead

Shanghai BDgene Co., Ltd.

INDUSTRY

NCT07170254 - A Clinical Study on the Evaluation of BD114 for the Treatment HPV-16-Related Cervical HSIL | Biotech Hunter | Biotech Hunter