Actively Recruiting
Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
Led by Newish Biotech (Wuxi) Co., Ltd. · Updated on 2026-02-17
150
Participants Needed
5
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV18.
CONDITIONS
Official Title
Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 60 years
- Histologically confirmed cervical HSIL with HPV16 and/or HPV18 positivity
- Satisfactory colposcopy showing clear visualization of lesions, with lesion area less than 75% of ectocervix surface
- Negative endocervical curettage if lesion upper border unclear
- Ability to understand and consent to the study and comply with all treatments and visits
- Normal or clinically insignificant electrocardiogram at screening
- Normal major organ function within 1 week before first dose as defined by blood, liver, and kidney tests
- Women of childbearing potential must agree to use reliable contraception throughout the study or be postmenopausal or sterilized
You will not qualify if you...
- Presence of cervical adenocarcinoma or other high-grade intraepithelial lesions or invasive cancer
- Pregnant, breastfeeding, or planning pregnancy during the study
- Received live vaccine within 4 weeks or non-live vaccine within 2 weeks before first dose
- Use of blood products within 3 months before first dose or planned during study
- Prior therapeutic HPV vaccine use
- Treatment for cervical HSIL within 4 weeks before first dose
- Metal implants or devices in electroporation area
- Participation in another clinical trial within 30 days before screening
- Recent systemic corticosteroid or immunosuppressive treatment except specified exceptions
- History of immunodeficiency or autoimmune diseases requiring systemic treatment
- Use of disease-modifying antirheumatic or biologic drugs during study
- History of organ or bone marrow transplant
- Active infections requiring systemic treatment
- Positive for hepatitis B, hepatitis C, syphilis, or HIV
- Active herpes zoster infection
- Severe organ dysfunction or cardiopulmonary diseases
- Epilepsy requiring medication
- History or current malignancy
- Severe allergies or allergic constitution
- Significant cardiac disease or poorly controlled hypertension
- Known psychiatric or substance abuse disorders interfering with study compliance
- Any condition or abnormality increasing risk or interfering with study as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, China, 100026
Actively Recruiting
3
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
5
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Actively Recruiting
Research Team
Y
Yang Xiang, M.D.
CONTACT
F
Fang Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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