An Open-Label, Two-Arm, Non-Randomized Clinical Study On The Safety And Efficacy Of Instantaneous CRISPR/Cas9 Gene Editing Therapy For Treating Chinese Patients With HPV-16-Related High-Grade Squamous Intraepithelial Lesions (HSIL)
Shanghai BDgene Co., Ltd. is advancing a novel CRISPR/Cas9 gene editing therapy (BD114) for the treatment of HPV-16-related high-grade squamous intraepithelial lesions (HSIL). The study is currently recruiting participants in Shanghai, China, with an estimated completion date in December 2026. The market for cervical cancer prevention and treatment is significant, particularly in regions with high HPV prevalence. If successful, BD114 could position BDgene as a leader in gene therapy for HPV-related conditions, although it will face competition from existing treatments and emerging therapies. Diligence should focus on regulatory pathways, potential market entry barriers, and the evolving landscape of gene editing technologies.
Indication: High-grade Squamous Intraepithelial Lesions (HSIL)
Modality: gene therapy
Target: CRISPR/Cas9 gene editing targeting HPV-16 E6/E7 genes.
Sponsor: Shanghai BDgene Co., Ltd.
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: CRISPR/Cas9 gene editing targeting HPV-16 E6/E7 genes.
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Condition raw: High-grade Squamous Intraepithelial Lesions (HSIL)
Condition normalized: High-grade Squamous Intraepithelial Lesions (HSIL)
Modality raw: gene therapy
Modality normalized: gene therapy
Target raw: CRISPR/Cas9 gene editing targeting HPV-16 E6/E7 genes.
Target normalized: CRISPR/Cas9 gene editing targeting HPV-16 E6/E7 genes.