Actively Recruiting
NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer
Led by Newish Technology (Beijing) Co., Ltd. · Updated on 2025-07-29
18
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 60 years for cohort A; women aged 18 years or older for cohort B
- Positive HPV16 test during screening
- Histologically confirmed HPV-16-associated cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL or HSIL) for cohort A
- Persistent HPV16 infection for more than 6 months if LSIL
- Satisfactory colposcopy with visible lesion areas if HSIL
- HPV16-related recurrent or metastatic advanced cervical cancer for cohort B
- At least one measurable lesion per RECIST 1.1 for cohort B
- ECOG performance status 0 or 1 for cohort B
- Recovery from prior anticancer therapy toxicities to grade 1 or baseline for cohort B
- Adequate major organ function as defined by blood counts, liver, kidney, and coagulation tests for cohort B
- Life expectancy of at least 3 months for cohort B
- Agreement to use reliable contraception during the trial and for 6 months after last dose if of childbearing potential
- Negative blood pregnancy test within 7 days prior to first dose for premenopausal women
- Ability to understand the study, communicate with investigators, and complete all treatments and visits
You will not qualify if you...
- Histologically confirmed adenocarcinoma, adenocarcinoma in situ, or invasive cancer for cohort A
- Pregnancy, breastfeeding, or planning to conceive during study
- Recent vaccination with live vaccines within 4 weeks or non-live vaccines within 2 weeks prior to first dose
- Treatment for LSIL or HSIL within 4 weeks prior to first dose for cohort A
- Participation in another clinical trial or observation period within 30 days prior to screening
- Continuous corticosteroid use (>1 week) equivalent to >10 mg/day prednisone within 30 days prior to screening except hormone replacement or local treatments
- History of immunodeficiency or autoimmune diseases
- Current or planned use of disease-modifying antirheumatic drugs or biological agents
- Continuous immunosuppressant use (>1 week) within 30 days prior to screening
- History of organ or bone marrow transplantation
- Past or current malignancies except certain cured cancers
- Uncontrolled severe infections or active infections including hepatitis B, C, HIV, syphilis
- Severe allergy history or atopic diseases
- Severe hypersensitivity or vaccine reactions
- Severe dysfunction of organs or heart and lung diseases
- Neurological or psychiatric disorders including epilepsy or dementia
- Drug abuse or alcoholism
- Positive pregnancy test or unwillingness to use contraception during and for 6 months after study
- Investigator's judgment deeming patient unsuitable for study
- Additional exclusions for cohort B include cervical carcinoma in situ curable by local treatment, unrecovered toxicities from prior treatments, CNS metastases, significant pleural/peritoneal/pericardial effusions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Heze Municipal Hospita
Heze, Shandong, China
Actively Recruiting
Research Team
G
Guodong Sun, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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