An Early Phase 1 interventional study of BD114VLP, or BD114 in High-grade Squamous Intraepithelial Lesions (HSIL), sponsored by Shanghai BDgene Co., Ltd.. Terminated at 1 site in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Shanghai BDgene Co., Ltd. · Early Phase 1, Interventional, and Treatment
This study is intented to evaluate the safety, and tolerability and preliminary efficacy of Instantaneous CRISPR/Cas9 Gene Editing Therapy (BD114 virus-like particle, also BD114) for the treatment of high-grade squamous intraepithelial lesions (HSIL) associated with HPV-16 infection.
This study is an open-label, two-arm, balanced-group, single-dose, non-randomized exploration clinical study. A total of 6 patients with HPV-16 Related HSIL of the Cervix will be enrolled and divided into two arms. Participant in Arm 1(n=1) receive topically low-dose of BD114 with intraepithelial injection of lesions, and participants in Arm 2 (n=5) receive high-dose of BD114 with intraepithelial injection of lesions. The total follow-up 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 or clearness and virologically HPV-16 clearness for efficacy evaluation are conducted and explored during follow-up visits.
22 studies on the registry are indexed under Squamous Intraepithelial Lesions; 16 are open to participants now.
This study's enrollment of 2 is below the median of 91 across 20 interventional studies indexed under Squamous Intraepithelial Lesions.
Browse Squamous Intraepithelial Lesions studies →Shanghai BDgene Co., Ltd. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
BD114 Low-dose group: Low-dose (n=1) * Small lesions (≤5 mm\^2): BD114 injection, 0.2 mL * Large lesions (\>5 mm\^2): BD114 injection 0.4 mL
Genetic: BD114VLP, or BD114
BD114 High-dose group: High-dose (n=5) * Small lesions (≤5 mm\^2): BD114 injection, 0.3 mL * Large lesions (\>5 mm\^2): BD114 injection 0.6 mL
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.
Adverse events (AEs) and serious adverse events (SAEs)
All AEs and SAEs occurring during the study period (from informed consent signing to Week 36 post-BD114 intervention) were recorded and assessed according to the NCI-CTCAE v5.0 grading system, including their classification by System Organ Class (SOC), severity grade, number of affected Participants, and incidence rates. Gynecological AEs (beyond NCI-CTCAE v5.0 specifications) shall be evaluated by investigators for classification and severity grading according to current clinical guidelines/expert consensus.
Time frame: ~36 weeks
Percentage of Participants with No Histologic Evidence of HSIL
Cervical tissue biopsies obtained at Week 24 and Week 36 undergo histopathological evaluation, and judge the HSIL Clearance by complete regression or disappear of the original lesions, with clearance rates calculated per the following formula: Percentage of Participants with No Histologic Evidence of HSIL (%) = Number of Participants Achieving HSIL Clearance / Total number of Participants treated with BD114 ×100%
Time frame: Week 24, Week 36
Percentage of Participants with No Histologic Evidence of HSIL and No Evidence of HPV-16
Virological HPV-16 assessment was performed using clinically validated type-specific HPV testing kits, meanwhile colposcopy-guided cervical tissue biopsies are histopathologically evaluated. The calculating formula as follow: Percentage of Participants with No Histologic Evidence of HSIL and No Evidence of HPV-16 = Number of Participants with No Histologic Evidence of HSIL and No Evidence of HPV-16 / Total number of Participants treated with BD114 ×100%
Time frame: Week 24, Week 36
Percentage of Participants with No Evidence of HPV-16
Histological samples (cervical exfoliated cells) is detected for HPV-16 by real-time fluorescent quantifying PCR technology. The calculating formula as follow: Percentage of Participants with No Evidence of HPV-16 = Number of Participants with No Evidence of HPV-16 / Total number of Participants treated with BD114 ×100%
Time frame: Week 24, Week 36
Percentage of Participants with No Evidence of HSIL or LSIL
Cervical biopsies at Week 36 are performed for histopathological evaluation, no histologically evidence of HSIL or LSIL of histological samples are judged as no histology findings of HSIL or LSIL. The calculating formula as follow: Percentage of Participants with No Evidence of HSIL or LSIL = Number of Participants with No Evidence of HSIL or LSIL / Total number of Participants treated with BD114 ×100%
Time frame: Week 36
Percentage of Participants with No Evidence of HSIL or LSIL and No Evidence of HPV-16
Cervical biopsies at Week 36 are performed for histopathological evaluation, no histologically evidence of HSIL or LSIL of histological samples are judged as no histology findings of HSIL or LSIL. Histological samples (cervical exfoliated cells) is detected HPV-16 by real-time fluorescent quantifying PCR technology. Calculation Formula: Percentage of Participants with No Evidence of HSIL or LSIL and No Evidence of HPV-16 = Number of Participants A with No Evidence of HSIL or LSIL and No Evidence of HPV-16 / Total number of Participants treated with BD114 ×100%
Time frame: Week 36
Changes in Serum Inflammatory Cytokine (IL-1/IL-6/TNF-α/IFN-γ) Levels Relative to Baseline
Blood samples were collected and analyzed using clinically validated ELISA kits to quantify serum levels of four inflammatory cytokines (IL-1, IL-6, TNF-α, and IFN-γ).
Time frame: Day0, Day 2, Week 1, Week 2, Week 4, Week 12, Week 24, and Week 36.
Concentrations of Cas9 Protein and gRNA in Peripheral Blood
The concentration of Cas9 protein are tested by ELISA and gRNA are detected by qPCR in blood.
Time frame: At Day0, Day 2, Week 1, Week 4, Week 12.
Detection of Anti-p24/Cas9 Protein Antibodies in Peripheral Blood
The detection of anti-p24/Cas9 protein antibodies in blood are performed at scheduled study visits.
Time frame: At Day0, Week 2, Week 4, Week 36
Off-Target Analysis
Off-Target analysis of cervical biopsy samples is conducted by applying DNA deep sequencing or whole genome sequencing (WGS) to assess BD114-related off-target effects based on the sequencing results.
Time frame: D0, Week 1
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Shanghai BDgene Co., Ltd.