Actively Recruiting
NWRD09 for HPV-16 Related Cervical HSIL
Led by Newish Biotech (Wuxi) Co., Ltd. · Updated on 2025-07-02
9
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open label, multi-center clinical study to evaluate the safety, tolerability and immunogenicity HPV16 targeted mRNA therapeutic vaccine (NWRD09) in HPV16 related cervical high-grade squamous intraepithelial lesions (HSlL).
CONDITIONS
Official Title
NWRD09 for HPV-16 Related Cervical HSIL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 18 and 65 years
- HPV16-positive patients with histologically confirmed cervical HSIL
- Adequate colposcopic examination allowing full visualization of the squamocolumnar junction and cervical lesions
- Normal major organ functions within 1 week before first NWRD09 administration, including blood counts, liver, and kidney function
- Negative blood pregnancy test within 7 days before first administration for premenopausal women of childbearing potential
- Agreement to use effective contraception during the trial and for at least 6 months after study end
- Ability to understand the study, communicate with investigators, and complete all treatments, examinations, and visits
You will not qualify if you...
- Histologically confirmed adenocarcinoma, adenocarcinoma in situ, or invasive cancer
- Pregnant, breastfeeding, or planning to conceive during the study
- Participation in another clinical trial or observation period within 30 days prior to screening
- Continuous use of corticosteroids (>10 mg/day prednisone equivalent) for more than 1 week within 30 days prior to screening (except certain hormone/local therapies)
- Continuous use of immunosuppressants for more than 1 week within 30 days prior to screening
- Receipt of any vaccine (live or non-live) within 4 weeks prior to first NWRD09 dose
- History of therapeutic HPV vaccination (preventive HPV vaccination allowed)
- HSIL treatment within 4 weeks prior to first NWRD09 dose
- Use of blood or blood-derived products within 3 months before first dose or planned use during study
- History of immunodeficiency or autoimmune diseases
- Current or planned use of disease-modifying antirheumatic drugs or biological agents during study
- History of solid organ or bone marrow transplantation
- Past or current malignancies except certain cured cancers more than 5 years prior
- Uncontrolled severe infections above Grade 2
- Positive test for HCV antibody, HIV antibody, or syphilis antibody (except specific controlled hepatitis B cases)
- History of severe or multiple hypersensitivity to drugs or pharmaceutical preparations
- Severe dysfunction of other organs or heart and lung diseases
- History of neurological or psychiatric disorders including epilepsy or dementia
- History of drug abuse or alcoholism
- Investigator judgment deeming patient unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yang Xiang
CONTACT
F
Fang Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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