Safety, Tolerability and Immunogenicity Study of NWRD09 in HPV16 Related Cervical High-grade Squamous Intraepithelial Lesions (HSlL)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

⁃ Patients had to meet all of the following 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.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Yang Xiang
xiangy@pumch.cn
86-010-69155635
Backup
Fang Jiang
13671170943@163.com
86-010-69155635
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 9
Treatments
Experimental: Dose1-3 of NWRD09
Patients will be assigned to three dose groups. Each patient will be administered NWRD09 by intramuscular injection. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
Related Therapeutic Areas
Sponsors
Leads: Newish Biotech (Wuxi) Co., Ltd.

This content was sourced from clinicaltrials.gov