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Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

14. července 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

156

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
      • Dalian, Čína
        • Dalian Maternal and Child Health Hospital
        • Kontakt:
          • Lu Han
        • Vrchní vyšetřovatel:
          • Lu Han, M.D.
    • Beijing Municipality
      • Beijing, Beijing Municipality, Čína
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
        • Kontakt:
          • Yi Yang, M.D.
          • Telefonní číslo: 86-010-69154187
          • E-mail: yangyi@pumch.cn
        • Vrchní vyšetřovatel:
          • Yi Yang, M.D.
      • Beijing, Beijing Municipality, Čína
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Yue He, M.D.
      • Beijing, Beijing Municipality, Čína
        • Peking University First Hospital
        • Kontakt:
          • Jian Zhao, M.D.
          • Telefonní číslo: 86-010-69119025
          • E-mail: 854496@qq.com
        • Vrchní vyšetřovatel:
          • Jian Zhao, M.D.
      • Beijing, Beijing Municipality, Čína
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Vrchní vyšetřovatel:
          • Bin Li, M.D.
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Nanan Lv, M.D.
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Čína
        • Chongqing University Cancer Hospital
        • Vrchní vyšetřovatel:
          • Dongling Zou, M.D.
        • Kontakt:
      • Chongqing, Chongqing Municipality, Čína
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
        • Kontakt:
          • Yanzhou Wang, M.D.
        • Vrchní vyšetřovatel:
          • Yanzhou Wang, M.D.
    • Gansu
      • Lanzhou, Gansu, Čína
        • Gansu Provincial Maternity and Child-care Hospital / Gansu Provincial central Hospital
        • Kontakt:
          • Ru lin, M.M.
        • Vrchní vyšetřovatel:
          • Ru Lin, M.M.
    • Hebei
      • Baoding, Hebei, Čína
        • Affiliated Hospital of Hebei University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Yijuan Liang, M.M.
    • Henan
      • Zhengzhou, Henan, Čína
        • The Second Affiliated Hospital of Zhengzhou University
        • Kontakt:
        • Kontakt:
          • Hui Chen, M.D.
          • Telefonní číslo: 86-0371-63930334
        • Vrchní vyšetřovatel:
          • Hui Chen, M.D.
    • Jiangsu
      • Nanjing, Jiangsu, Čína
        • Nanjing Maternity and Child Health Care Hospital
        • Kontakt:
        • Kontakt:
          • Boqun Xu, M.D.
          • Telefonní číslo: 86-025-52226919
        • Vrchní vyšetřovatel:
          • Boqun Xu, M.M.
    • Jilin
      • Changchun, Jilin, Čína
        • The Second Hospital of Jilin University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Tianmin Xu, M.D.
    • Shandong
      • Jinan, Shandong, Čína
        • Qilu Hospital of Shandong University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Youzhong Zhang, M.D.
    • Shanxi
      • Taiyuan, Shanxi, Čína
        • Shanxi Maternal and Child Health Hospital
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Xiaoli Li, M.M.
      • Xi’an, Shanxi, Čína
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Kontakt:
          • Ruifang An, M.D.
          • Telefonní číslo: 86-029-85323473
        • Vrchní vyšetřovatel:
          • Ruifang An, M.D.

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 10 ug NWRD09
Biologický: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Experimentální: 20 ug NWRD09
Biologický: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Komparátor placeba: Placebo for the 10 ug NWRD09 arm
Biologický: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
Komparátor placeba: Placebo for the 20 ug NWRD09 arm
Biologický: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence and severity of local and systemic adverse events (AEs).
Časové okno: 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).
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Newish Biotech (Wuxi) Co., Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

30. června 2027

Dokončení studie (Odhadovaný)

30. prosince 2027

Termíny zápisu do studia

První předloženo

8. července 2026

První předloženo, které splnilo kritéria kontroly kvality

14. července 2026

První zveřejněno (Aktuální)

17. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NWRD09-202

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

All IPD that underlie results in a publication

Časový rámec sdílení IPD

6 months after publication

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na NWRD09 Injection

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Kosovo

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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