RecruitingNot ApplicableNCT06741150

NWRD09 for HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.

Safety and Efficacy Study of NWRD09 in HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.


Sponsor

Newish Technology (Beijing) Co., Ltd.

Enrollment

18 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open label, two cohorts, multi-center clinical study to evaluate the safety and efficacy of HPV-16 targeted mRNA vaccine (NWRD09) in HPV-16 positive and HPV-16 related cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests a therapeutic vaccine called NWRD09 in women with HPV-16 related cervical abnormalities or cervical cancer. HPV-16 is the most common strain of human papillomavirus linked to cervical cancer. The vaccine aims to train the immune system to attack HPV-16-infected cells. **You may be eligible if...** - You are a woman between 18 and 60 years old - You have tested positive for HPV-16 - You have high-grade cervical cell changes (HSIL) or early-stage cervical cancer - Your colposcopy exam showed the abnormal area is fully visible (satisfactory colposcopy) **You may NOT be eligible if...** - You are outside the age range of 18–60 - Your HPV test is negative for HPV-16 - The abnormal cervical area cannot be fully visualized during colposcopy - You have health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNWRD09 administered by intramuscular injection

Intramuscular injection administration was carried out according to the protocol design.


Locations(1)

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

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NCT06741150


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