이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Evaluation of NWRD09 for HPV-16 Related Cervical HSIL

2026년 7월 14일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

156

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 10 ug NWRD09
생물학적: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
실험적: 20 ug NWRD09
생물학적: NWRD09 Injection
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
위약 비교기: Placebo for the 10 ug NWRD09 arm
생물학적: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
위약 비교기: Placebo for the 20 ug NWRD09 arm
생물학적: NWRD09 Placebo
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of local and systemic adverse events (AEs).
기간: 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).
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Newish Biotech (Wuxi) Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 6월 30일

연구 완료 (추정된)

2027년 12월 30일

연구 등록 날짜

최초 제출

2026년 7월 8일

QC 기준을 충족하는 최초 제출

2026년 7월 14일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 14일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NWRD09-202

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

All IPD that underlie results in a publication

IPD 공유 기간

6 months after publication

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

NWRD09 Injection에 대한 임상 시험

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스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Turkmenistan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다