Clinical Trial

Disease: High-grade Squamous Intraepithelial Lesions, HSIL, (NCT07170254)

Disease info:

A squamous intraepithelial lesion (SIL) is a localised area of disorganised epithelial cell growth on the surface of the skin or mucosa, commonly affecting the cervix, vagina, vulva, anus, penis, or oropharynx. SILs are caused primarily by human papillomavirus (HPV), a sexually transmitted infection. While the lesions themselves are not infectious, HPV can be transmitted through sexual contact. The hallmark of SILs is that the abnormal cells remain confined to the epithelial layer, without invading deeper tissue, which is why they are considered precancerous. Early detection is crucial to prevent progression to invasive cancer.

SILs are classified as low-grade (LSIL) or high-grade (HSIL). LSILs, or mild dysplasia, exhibit only minor cellular abnormalities and may resolve spontaneously, whereas HSILs, comprising moderate to severe dysplasia and carcinoma, display pronounced cellular atypia and generally require prompt treatment to reduce the risk of malignant transformation. SILs are usually asymptomatic and are often identified through routine screenings, such as Pap smears, cervical, vaginal, or anal cytology, or anoscopy. 

HPV is responsible for approximately 90% of SILs. High-risk HPV types, particularly 16 and 18, are most often associated with high-grade lesions, while types 6 and 11 commonly lead to low-grade lesions. Other high-risk strains can also contribute. 

Squamous Intraepithelial Lesion (SIL): Causes & Treatment

Frequency:
According to one study approximately 0.3% of all PAPs are interpreted as HSIL, almost all (95%) of which are HR-HPV positive. - https://pmc.ncbi.nlm.nih.gov/articles/PMC8326095/
Official title:
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)
Who:

Contact 

Name: Fujun Li, M.D.

Phone: 086-191 2131 1061

Email: fujun.li@bdgene.cn

Contact Backup

Name: Long Sui, M.D.

Phone: 086-138 0178 8118

Email: suilong@sh163.net

Sponsor:

Shanghai BDgene Co., Ltd.
 

Partners:
Locations:

Shanghai, China

Obstetrics & Gynecology Hospital of Fudan University, Shanghai, China, 200090

Study start:
Sep. 1, 2025
Enrollment:
12 participants
Gene editing method:
CRISPR-Cas9
Gene:
Delivery method:
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This study is an open-label, two-arm, balanced-group, single-dose, non-randomized exploration clinical study. A total of 12 patients with HPV-16 Related HSIL of the Cervix will be enrolled and divided into two arms. Participants in Arm 1 receive topically BD114 intraepithelial injection of lesions, and Participants in Arm 2 receive BD114 gel topical application of lesions, with 6 Participants allocated in each arm. Each study arm is further divided into the low-dose subgroup assigned 1 Participant and the high-dose subgroup assigned 5 Participants. The total study duration for each Participant is 40 weeks (including screening stage). The treatment-emergent adverse events (TEAEs) for safe evaluation, components detection of the BD114 for pharmacokinetics (PK) assessment, histologically lesion regression and virologically HPV-16 clearness for efficacy evaluation are observed and explored during follow-up visits.

Last updated: Sep. 18, 2025
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