NWRD09 for HPV-16 Related Cervical HSIL

NCT07047989 | Recruiting Phase 1

• 1 other identifier: NWRD09-102
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

High-grade Squamous Intraepithelial Lesion (HSIL)

Keywords

NWRD09; mRNA vaccine; HPV16; HSIL

Outcome Measures

Primary Outcomes (2)

• Safety

  All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events).

  To week 24

• Dose-limiting toxicity (DLT)

  It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the third dosing will be classified as DLT during dosing climb.

  Within 28 days of the third dosing

Secondary Outcomes (3)

• Immunogenicity

  Week 4、8、16、24、48

• Histopathology outcome and HPV Viral clearance

  Week 24.

• The recommended phase II dose (RP2D)

  Week 24

Study Arms (1)

Dose1-3 of NWRD09

EXPERIMENTAL

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.

Biological: NWRD09 injection

Interventions

NWRD09 injection BIOLOGICAL

NWRD09 administered by intramuscular injection

Dose1-3 of NWRD09

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 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.
• 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 than 5 years before entering the study.
• Uncontrolled severe infections (\>Grade 2 NCI-CTCAE adverse events, version 5.0).

Sponsors & Collaborators

• Newish Biotech (Wuxi) Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Xiang

CONTACT

86-010-69155635; xiangy@pumch.cn

Fang Jiang

CONTACT

86-010-69155635; 13671170943@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)