Actively Recruiting
NWRD09 for HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.
Led by Newish Technology (Beijing) Co., Ltd. · Updated on 2024-12-18
18
Participants Needed
1
Research Sites
79 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 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).
CONDITIONS
Official Title
NWRD09 for HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged between 18 and 60 years for cohort A
- Positive for HPV16 during screening; other HPV co-infections allowed
- For HSIL patients, satisfactory colposcopy with fully visible lesions
- Women of childbearing potential must agree to use reliable contraception during the trial and for 6 months after last dose
- Negative blood pregnancy test within 7 days before first dose for premenopausal women
- Able to understand and voluntarily sign informed consent and complete all study procedures
- Women aged 18 years or older for cohort B
- Histologically confirmed HPV16-related recurrent or metastatic advanced cervical cancer with progression after at least two standard therapies or intolerant to them
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Recovery from prior anticancer therapy toxicities to grade 1 or baseline except certain asymptomatic lab abnormalities
- Adequate major organ function as defined by specified blood counts, liver, renal, and coagulation tests
- Life expectancy of at least 3 months
- Women of childbearing potential must agree to use reliable contraception during the trial and for 6 months after last dose
- Negative blood pregnancy test within 7 days before first dose for premenopausal women
- Able to understand and voluntarily sign informed consent and complete all study procedures
You will not qualify if you...
- Histopathologically confirmed adenocarcinoma, adenocarcinoma in situ, or invasive cancer for cohort A
- Pregnant, breastfeeding, or planning pregnancy during the study
- Received non-live vaccine within 2 weeks or live vaccine within 4 weeks before 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 (>10 mg/day prednisone equivalent) for more than 1 week within 30 days before screening except for specified exceptions
- History of immunodeficiency, autoimmune diseases, or current use of immunosuppressive or disease-modifying antirheumatic drugs
- History of solid organ or bone marrow transplantation
- Past or current malignancies except certain cured conditions over 5 years prior
- Uncontrolled severe infections or active infections including hepatitis B, C, HIV, syphilis, herpes zoster
- Severe allergy, atopic diseases, or history of severe hypersensitivity to drugs or vaccines
- Severe organ dysfunction or heart and lung diseases
- History of neurological or psychiatric disorders including epilepsy or dementia
- History of drug abuse or alcoholism
- Positive blood pregnancy test or unwillingness to use effective contraception during and for 6 months after the study
- Patients deemed unsuitable by investigator
- Cervical carcinoma in situ curable by local treatment or non-HPV related cervical cancer for cohort B
- Not recovered from toxicities related to prior treatments
- Central nervous system metastases or carcinomatous meningitis
- Clinically significant pleural, peritoneal, or pericardial effusion requiring frequent drainage
- Other criteria similar to cohort A regarding vaccines, corticosteroids, immunosuppressants, infections, allergies, organ dysfunction, pregnancies, and investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China, 214062
Actively Recruiting
Research Team
Y
Yong Mao, M.D.
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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