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Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

14 luglio 2026 aggiornato da: Newish Biotech (Wuxi) Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD09 in Patients With HPV16-Positive Cervical High-Grade Squamous Intraepithelial Lesion (HSIL)

This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD09 administered by intramuscular (IM) injection in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase II, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD09 in patients with HPV16 positive cervical high-grade squamous intraepithelial lesion (HSIL). Eligible participants are randomized to receive either NWRD09 or the corresponding placebo.

Participants will receive intramuscular injections of either NWRD09 or matching placebo at the corresponding dose at weeks 0, 2, 4, and 12 (a total of 4 doses).

Efficacy evaluations at Week 24 will include histopathological biopsy and HPV testing.

Tipo di studio

Interventistico

Iscrizione (Stimato)

156

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Dalian, Cina
        • Dalian Maternal and Child Health Hospital
        • Contatto:
          • Lu Han
        • Investigatore principale:
          • Lu Han, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Contatto:
        • Investigatore principale:
          • Yi Yang, M.D.
      • Beijing, Beijing Municipality, Cina
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
        • Contatto:
        • Investigatore principale:
          • Yue He, M.D.
      • Beijing, Beijing Municipality, Cina
        • Peking University First Hospital
        • Contatto:
          • Jian Zhao, M.D.
          • Numero di telefono: 86-010-69119025
          • Email: 854496@qq.com
        • Investigatore principale:
          • Jian Zhao, M.D.
      • Beijing, Beijing Municipality, Cina
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Investigatore principale:
          • Bin Li, M.D.
        • Contatto:
        • Sub-investigatore:
          • Nanan Lv, M.D.
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Cina
        • Chongqing University Cancer Hospital
        • Investigatore principale:
          • Dongling Zou, M.D.
        • Contatto:
      • Chongqing, Chongqing Municipality, Cina
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
        • Contatto:
          • Yanzhou Wang, M.D.
        • Investigatore principale:
          • Yanzhou Wang, M.D.
    • Gansu
      • Lanzhou, Gansu, Cina
        • Gansu Provincial Maternity and Child-care Hospital / Gansu Provincial central Hospital
        • Contatto:
          • Ru lin, M.M.
        • Investigatore principale:
          • Ru Lin, M.M.
    • Hebei
      • Baoding, Hebei, Cina
        • Affiliated Hospital of Hebei University
        • Contatto:
        • Investigatore principale:
          • Yijuan Liang, M.M.
    • Henan
      • Zhengzhou, Henan, Cina
        • The Second Affiliated Hospital of Zhengzhou University
        • Contatto:
        • Contatto:
          • Hui Chen, M.D.
          • Numero di telefono: 86-0371-63930334
        • Investigatore principale:
          • Hui Chen, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, Cina
        • Nanjing Maternity and Child Health Care Hospital
        • Contatto:
        • Contatto:
          • Boqun Xu, M.D.
          • Numero di telefono: 86-025-52226919
        • Investigatore principale:
          • Boqun Xu, M.M.
    • Jilin
      • Changchun, Jilin, Cina
        • The Second Hospital of Jilin University
        • Contatto:
        • Investigatore principale:
          • Tianmin Xu, M.D.
    • Shandong
      • Jinan, Shandong, Cina
        • Qilu Hospital of Shandong University
        • Contatto:
        • Investigatore principale:
          • Youzhong Zhang, M.D.
    • Shanxi
      • Taiyuan, Shanxi, Cina
        • Shanxi Maternal and Child Health Hospital
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Xiaoli Li, M.M.
      • Xi’an, Shanxi, Cina
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contatto:
          • Ruifang An, M.D.
          • Numero di telefono: 86-029-85323473
        • Investigatore principale:
          • Ruifang An, M.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

Participants had to meet all of the following inclusion criteria:

  1. Age between 18 and 65 years (inclusive), female;
  2. Confirmed by the central laboratory: histopathologically diagnosed cervical high-grade squamous intraepithelial lesion (HSIL) and HPV genotyping positive for HPV16;
  3. Colposcopy results at each study center during the screening period must meet the following criteria:

1) The colposcopy examination is adequate, allowing clear visualization of the entire area of acetowhite epithelium or suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper margin of the lesion; 2) If the upper margin of the lesion is not clearly visible, the endocervical curettage (ECC) result must be negative; 3) The area of cervical lesion is less than 75% of the cervical area visible by colposcopy; (4) Within 14 days (inclusive) before the first dose, major organ function meets the following criteria:

  1. Hematology: hemoglobin (Hb) ≥ 100 g/L; platelet count (PLT) ≥ 75 × 10⁹/L; absoluteneutrophil count ≥ 1.8 × 10⁹/L;
  2. 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 (Cr) ≤ 1.5 × ULN, or creatinine clearance (Ccr) ≥ 40 mL/min (calculated by Cockcroft-Gault formula); (5) For premenopausal women with childbearing potential, serum pregnancy test within 14 days before the first dose must be negative. Eligible participants of childbearing potential and their spouse/partner must agree to use effective contraceptive measures during the study period or until 64 weeks after the first dose; (6) Fully understand the study and voluntarily sign the informed consent form (ICF), be able to communicate well with the investigator, and be able to complete all treatments, examinations, and visits as required by the study protocol.

Exclusion Criteria:

Participants with any of the following were excluded from the study:

  1. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), vulvar, vaginal, or anal high-grade intraepithelial lesions, or invasive cancer;
  2. Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period;
  3. Participation in another clinical trial within 30 days prior to screening, or currently being in the follow-up period of another clinical trial;

  4. Continuous use (for more than 1 week) of systemic glucocorticoid therapy (at a dose equivalent to >10 mg/day prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 30 days prior to screening, except for the following:

    1. Inhaled, ophthalmic, or topical glucocorticoid therapy at a dose ≤10 mg/day prednisone or equivalent is permitted;
    2. Physiological glucocorticoid replacement therapy at a dose ≤10 mg/day prednisone or equivalent;
  5. Continuous use (for more than 1 week) of immunosuppressants such as cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, anti-lymphocyte globulin, etc., within 30 days prior to screening;
  6. Receipt of any live vaccine within 4 weeks prior to the first dose, and/or any non-live vaccine within 2 weeks prior to the first dose;
  7. Any history of therapeutic HPV vaccination (approved prophylactic HPV vaccination is acceptable);
  8. Receipt of any drug or physical therapy for HSIL within 4 weeks prior to screening;
  9. Use of blood or blood-related products (including immunoglobulin) within 3 months prior to the first dose, or planned use during the study period;
  10. History of immunodeficiency or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.), or currently active autoimmune disease requiring systemic treatment (e.g., with disease-modifying agents, corticosteroids, or immunosuppressants);
  11. Current or anticipated continuous use (for more than 1 week) of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease-modifying antirheumatic drugs (e.g., infliximab, adalimumab, etanercept) during the study period;
  12. History of solid organ or bone marrow transplantation;
  13. Previous or current other malignancy;
  14. Uncontrolled serious infection (> Grade 2 NCI-CTCAE, version 6.0);
  15. Positive test for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; positive for hepatitis B surface antigen (HBsAg) unless HBV-DNA ≤ 2500 copies/mL or ≤ 500 IU/mL or within the normal range of the study site;
  16. Known allergy to any component of the investigational drug or similar drugs; history of severe allergic reactions to food, drugs, or other substances (e.g., urticaria, eczema, dyspnea, angioedema, etc.);
  17. Tattoos, scars, or active lesions/rash within 2 cm of the intended injection site (deltoid of the upper arm) that may affect safety observation;
  18. Severe dysfunction of other organs or cardiopulmonary disease;
  19. Definite history of neurological or psychiatric disorders, including epilepsy or dementia;
  20. History of drug abuse or alcohol use disorder;
  21. History or current evidence of any condition, treatment, laboratory abnormality, or other circumstances that may increase the risk of study participation or investigational product administration, or may interfere with interpretation of study results, and in the judgment of the investigator, make the participant unsuitable for enrollment in this study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 10 ug NWRD09
Biologico: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Sperimentale: 20 ug NWRD09
Biologico: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Comparatore placebo: Placebo for the 10 ug NWRD09 arm
Biologico: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
Comparatore placebo: Placebo for the 20 ug NWRD09 arm
Biologico: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
Lasso di tempo: Week24
The number of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to CIN 1 or no lesions at the 24 week visit.
Week24

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence and severity of local and systemic adverse events (AEs).
Lasso di tempo: Up to week 64
Based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V6.0, adverse events (AEs) and serious adverse events (SAEs) will be monitored.
Up to week 64
Incidence and severity of all serious adverse events (SAEs).
Lasso di tempo: Up to week 64
Incidence and severity of all serious adverse events (SAEs) during the study period (e.g., suspected unexpected serious adverse reactions, unexpected adverse device effects).
Up to week 64
Pregnancy occurrences and outcomes during the study period.
Lasso di tempo: Up to week 64
Pregnancy occurrences and outcomes during the study period
Up to week 64
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Lasso di tempo: Up to week 64
Incidence of AEs leading to discontinuation of study treatment that are related to the investigational product.
Up to week 64
Proportion of Participants with Histopathological Regression of Cervical Lesions to no lesions.
Lasso di tempo: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to no lesions at the 24 week visit.
Week 24
Proportion of Participants with Histopathological regression of Cervical Lesions to LSIL/CIN1.
Lasso di tempo: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to LSIL/CIN1 at the 24 week visit.
Week 24
Proportion of Participants with Virologically-proven Clearance of HPV 16.
Lasso di tempo: Week 24
Proportion of participants with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL(LSIL /CIN1 or lesion) and with Virologically-proven Clearance of HPV 16.
Lasso di tempo: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to LSIL/CIN1 or no lesion and with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression of Cervical Lesions to no Lesion and with Virologically-proven Clearance of HPV 16.
Lasso di tempo: Week 24
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress completely to no lesion and with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression to non-HSIL (LSIL/CIN1 or no lesion) in Participants with Baseline HPV16-only Infection.
Lasso di tempo: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and HPV16-only infection whose cervical lesions regress histopathologically to non-HSIL (LSIL/CIN1 or no lesion) at week 24 visit.
Week 24
Proportion of Participants with Histopathological Regression to no Lesion in Participants with Baseline HPV16-only Infection.
Lasso di tempo: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and HPV16-only infection whose cervical lesions regress histopathologically to no lesion at week 24 visit.
Week 24
Proportion of Participants with Virologically-proven Clearance of Both HPV16 and non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
Lasso di tempo: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and co-infection with non-HPV16 who achieve clearance of both HPV16 and non-HPV16 on cervical genotyping at week 24 visit.
Week 24
Proportion of Participants with Virologically-proven Clearance of non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
Lasso di tempo: Week 24
Proportion of participants with baseline cervical HSIL (CIN2/3) and co-infection with non-HPV16 who achieve clearance of non-HPV16 on cervical genotyping at week 24 visit.
Week 24
Levels of cellular immune responses.
Lasso di tempo: Weeks 4, 8, 16, 24 and 48
Levels of cellular immune responses measured by interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT) assay in peripheral blood mononuclear cells (PBMCs) of subjects at baseline and at Weeks 4, 8, 16,24 and 48.
Weeks 4, 8, 16, 24 and 48
Levels of serum anti-HPV16 antibody titers.
Lasso di tempo: Weeks 4, 8, 16, 24 and 48
Levels of serum anti-HPV16 antibody titers measured in peripheral blood samples collected at baseline and at Weeks 4, 8, 16, 24 and 48.
Weeks 4, 8, 16, 24 and 48

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Newish Biotech (Wuxi) Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 dicembre 2027

Date di iscrizione allo studio

Primo inviato

8 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NWRD09-202

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

All IPD that underlie results in a publication

Periodo di condivisione IPD

6 months after publication

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

Malattie rare

Interventi farmacologici

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Sponsor / Collaboratori

Sedi

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