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Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

14. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

156

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 10 ug NWRD09
Biologisk: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Eksperimentel: 20 ug NWRD09
Biologisk: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Placebo komparator: Placebo for the 10 ug NWRD09 arm
Biologisk: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
Placebo komparator: Placebo for the 20 ug NWRD09 arm
Biologisk: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence and severity of local and systemic adverse events (AEs).
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Newish Biotech (Wuxi) Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. december 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NWRD09-202

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

All IPD that underlie results in a publication

IPD-delingstidsramme

6 months after publication

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Højgradig pladeepitellæsion (HSIL)

Kliniske forsøg med NWRD09 Injection

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