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New treatment option for High-grade Squamous Intraepithelial Lesion (HSIL)
Official title Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
ClinicalTrials.gov ID: NCT07175662
What this study is testing
What is NWRD08 administered by electroporation?
NWRD08 administered by electroporation is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for high-grade squamous intraepithelial lesion (hsil).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- people had to meet all of the following 1\. Aged 18 to 60 years, female. 2\. Confirmed by the central laboratory, histopathology results demonstrated...
- The colposcopy must be satisfactory, allowing clear visualization of the entire acetowhite area or the extent of suspected cervical intraepithelial...
- If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
- The cervical lesion area must be less than 75% of the surface of the ectocervix. 4\. Fully understand the study and voluntarily sign the informed...
- Hormonal contraceptives: Combined or progestin-only methods, including oral contraceptives, injections, implants, vaginal rings, or transdermal...
You likely can't join if
- Patients with any of the following were excluded from the study:
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions...
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Administration of any live vaccine within 4 weeks prior to the first dose and/or any non-live vaccine within 2 weeks prior to the first dose.
- Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
- Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before screening.
See the full eligibility criteria
Who can join
- people had to meet all of the following 1\. Aged 18 to 60 years, female. 2\. Confirmed by the central laboratory, histopathology results demonstrated cervical HSIL with concurrent HPV16 and/or HPV18 positivity. 3\...
- The colposcopy must be satisfactory, allowing clear visualization of the entire acetowhite area or the extent of suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper border of the lesion.
- If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
- The cervical lesion area must be less than 75% of the surface of the ectocervix. 4\. Fully understand the study and voluntarily sign the informed consent form, able to communicate well with the investigator and complete...
- Hormonal contraceptives: Combined or progestin-only methods, including oral contraceptives, injections, implants, vaginal rings, or transdermal patches. people with a history of hypercoagulable states (e.g., deep vein...
- Abstinence from penile-vaginal intercourse.
- Intrauterine device (IUD) or intrauterine system (IUS).
- Female subject's male partner sterilized for at least 6 months prior to study entry, and this male is the subject's sole sexual partner.
- Condom use, with emergency contraception required in case of accidents such as slippage or breakage.
- Postmenopausal patients (defined as at least 12 consecutive months of amenorrhea without alternative medical causes, with serum follicle-stimulating hormone levels within the laboratory reference range for...
What rules you out
- Patients with any of the following were excluded from the study:
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Administration of any live vaccine within 4 weeks prior to the first dose and/or any non-live vaccine within 2 weeks prior to the first dose.
- Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
- Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before screening.
- Treatment for cervical HSIL within 4 weeks prior to the first dose.
- Presence of metal implants or implantable medical devices within the electroporation area.
- Participation in another clinical trial within 30 days prior to screening or being in the follow-up period of another clinical trial.
- Continuous (for more than 1 week) systemic treatment with corticosteroids (at a dose equivalent to \>10 mg/day prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 30 days...
- Inhaled, ophthalmic, or topical use of corticosteroids at doses ≤10 mg/day prednisone or equivalent is permitted.
- Physiological corticosteroid replacement therapy at doses ≤10 mg/day prednisone or equivalent is permitted.
- History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.) or current active autoimmune diseases requiring systemic treatment (e.g., use of...
- Current or anticipated use of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease-modifying drugs (e.g., infliximab, adalimumab, etanercept)...
- Continuous (for more than 1 week) use of immunosuppressants such as cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and antilymphocyte globulin, as well as other inhibitors affecting immune function (e.g...
- History of solid organ or bone marrow transplantation.
- Active infections requiring systemic treatment (including active tuberculosis, active Treponema pallidum infection, and bacterial, fungal, or viral infections requiring systemic therapy).
- Positive test results for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (anti-HIV).
- Participants with active herpes zoster virus infection.
- Participants with severe dysfunction of other organs or cardiopulmonary diseases.
- Epilepsy requiring medication (e.g., steroids or antiepileptic drugs).
- History or current diagnosis of malignancy.
- History of severe allergies, allergic diseases, or allergic constitution, meeting any of these criteria.
- Evidence or history of clinically significant cardiac disease, including but not limited to: 1) Congestive heart failure (NYHA Class \>2). 2) Unstable angina. 3) Myocardial infarction within the past 3 months. 4) Any...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Taiyuan, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Taiyuan, Shanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.