NWRD09 for HPV-16 Related Cervical HSIL (NCT07047989) | Clinical Trial Compass
RecruitingPhase 1
NWRD09 for HPV-16 Related Cervical HSIL
China9 participantsStarted 2025-06-12
Plain-language summary
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).
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion criteria
✓. 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 (ClN) lesions, including the upper boundary of the lesion.
✓. 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 normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Plasma albumin ≥30 g/L; 3)Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥40mL/min (Cockcroft-Gault);
✓. 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 subjects with reproductive capacity, as well as their spouses/partners, must agree to use effective contraceptive measures during the trial period or for at least 6 month safter the end-of-study visit (Week 24).
✓. 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.
Exclusion criteria
✕. 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 treatments.
✕. 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.