RecruitingNot ApplicableNCT07092007

NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer

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


Sponsor

Newish Technology (Beijing) Co., Ltd.

Enrollment

18 participants

Start Date

Jun 5, 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 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 NWRD09, an investigational therapeutic vaccine designed to target HPV-16 (human papillomavirus type 16) — the strain responsible for most HPV-related cancers. It is being tested in women with HPV-16-associated precancerous or cancerous cervical, vaginal, or vulvar lesions. **You may be eligible if...** - You are a woman aged 18–60 - You tested positive for HPV-16 - You have a confirmed diagnosis of HPV-16-associated precancerous or cancerous lesions of the cervix, vagina, or vulva - For precancerous (LSIL) lesions: you must have had persistent HPV-16 infection **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have a weakened immune system or are on immunosuppressive therapy - You have received prior HPV vaccines - You have active, serious infections 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

NWRD09 administered by intramuscular injection according to the study protocol.


Locations(1)

Heze Municipal Hospita

Heze, Shandong, China

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NCT07092007


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