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New treatment option for High-grade Squamous Intraepithelial Lesion (HSIL)
Official title NWRD09 for HPV-16 Related Cervical HSIL
ClinicalTrials.gov ID: NCT07047989
What this study is testing
What is NWRD09 injection?
NWRD09 injection is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for high-grade squamous intraepithelial lesion (hsil).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65, women only
You may be able to join if
- Patients had to meet all of the following
- Women aged between 18 and 65 years.
- HPV16-positive patients with histologically confirmed cervical HSlL.
- Colposcopic examination should be adequate, enabling clear visualization of the entire squamocolumnar junction(SCJ), as well as the full extent of...
- Major organ functions were normal within 1 week before the first NWRD09 administration: 1) Blood routine: Hemoglobin (Hb) ≥100 g/L; Platelet count...
You likely can't join if
- Patients with any of the following were excluded from the study:
- Any histologically confirmed adenocarcinoma or adenocarcinoma in situ (AIS) or invasive cancer.
- Pregnant, breastfeeding, or planning to conceive during the study period.
- Participated in another clinical trial or is in the observation period of another clinical trial within 30 days prior to screening.
- Continuous (more than 1 week) use of corticosteroids (equivalent to \>10 mg/day of prednisone) within 30 days prior to screening, except for hormone...
- Continuous (more than 1 week) use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and anti-lymphocyte...
See the full eligibility criteria
- Patients had to meet all of the following
- Women aged between 18 and 65 years.
- HPV16-positive patients with histologically confirmed cervical HSlL.
- Colposcopic examination should be adequate, enabling clear visualization of the entire squamocolumnar junction(SCJ), as well as the full extent of acetowhite staining or suspected cervical intraepithelial neoplasia...
- Major organ functions were normal within 1 week before the first NWRD09 administration: 1) Blood routine: Hemoglobin (Hb) ≥100 g/L; Platelet count (PLT) ≥75×109/L; 2) The liver: Total bilirubin (TB) ≤1.5× upper limit of...
- For premenopausal women of child bearing potential, a blood pregnancy test must yield a negative result within 7 days prior to the first administration of the investigational drug; eligible people with reproductive...
- Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.
- Patients with any of the following were excluded from the study:
- Any histologically confirmed adenocarcinoma or adenocarcinoma in situ (AIS) or invasive cancer.
- Pregnant, breastfeeding, or planning to conceive during the study period.
- Participated in another clinical trial or is in the observation period of another clinical trial within 30 days prior to screening.
- Continuous (more than 1 week) use of corticosteroids (equivalent to \>10 mg/day of prednisone) within 30 days prior to screening, except for hormone replacement therapy and local administration such as inhaled or ocular...
- Continuous (more than 1 week) use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and anti-lymphocyte globulin) within 30 days prior to screening.
- Received any non-live/live vaccine injection within 4 weeks prior to the first dose of NWRD09.
- Any history of therapeutic HPV vaccination (previously approved preventive HPV vaccination is acceptable).
- Received treatment HSIL within 4 weeks prior to the first dose of NWRD09.
- Prohibited: Use of blood/blood-derived products (e.g., immunoglobulins) within 3 months before first dose or intended use during the study.
- History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
- Current or anticipated use of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biological agents (e.g., infliximab, adalimumab, etanercept) during the study.
- History of solid organ or bone marrow transplantation.
- Past or current malignancies, except for adequately treated and completely cured ductal carcinoma in situ of the breast, basal cell carcinoma of the skin, superficial bladder tumors, or any other malignancies cured more...
- Uncontrolled severe infections (\>Grade 2 NCI-CTCAE adverse events, version 5.0).
- Patients who test positive for any of the following: hepatitis C virus (HCV)antibody, human immunodeficiency virus (HlV) antibody, or syphilis treponema antibody; except those with abnormal hepatitis B serology (i.e...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.