High-grade Squamous Intraepithelial Lesion (HSIL)Phase 2NCT07712692
Evaluation of NWRD09 for HPV-16 Related Cervical HSIL
A Phase 2 study testing NWRD09 Injection in people with High-grade Squamous Intraepithelial Lesion (HSIL), run by Newish Biotech (Wuxi) Co., Ltd. at 15 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- High-grade Squamous Intraepithelial Lesion (HSIL)
- What is being tested?
- NWRD09 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 15 sitesChina
- Study dates
- 1 Aug 2026to 30 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants had to meet all of the following inclusion criteria:
- Age between 18 and 65 years (inclusive), female;
- Confirmed by the central laboratory: histopathologically diagnosed cervical high-grade squamous intraepithelial lesion (HSIL) and HPV genotyping positive for HPV16;
- 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:
- Hematology: hemoglobin (Hb) ≥ 100 g/L; platelet count (PLT) ≥ 75 × 10⁹/L; absoluteneutrophil count ≥ 1.8 × 10⁹/L;
- 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;
- 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.
Who cannot join
- Participants with any of the following were excluded from the study:
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), vulvar, vaginal, or anal high-grade intraepithelial lesions, or invasive cancer;
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period;
- Participation in another clinical trial within 30 days prior to screening, or currently being in the follow-up period of another clinical trial;
- 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:
- Inhaled, ophthalmic, or topical glucocorticoid therapy at a dose ≤10 mg/day prednisone or equivalent is permitted;
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- Physiological glucocorticoid replacement therapy at a dose ≤10 mg/day prednisone or equivalent;
- 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;
- 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;
- Any history of therapeutic HPV vaccination (approved prophylactic HPV vaccination is acceptable);
- Receipt of any drug or physical therapy for HSIL within 4 weeks prior to screening;
- Use of blood or blood-related products (including immunoglobulin) within 3 months prior to the first dose, or planned use during the study period;
- 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);
- 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;
- History of solid organ or bone marrow transplantation;
- Previous or current other malignancy;
- Uncontrolled serious infection (> Grade 2 NCI-CTCAE, version 6.0);
- 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;
- 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.);
- Tattoos, scars, or active lesions/rash within 2 cm of the intended injection site (deltoid of the upper arm) that may affect safety observation;
- Severe dysfunction of other organs or cardiopulmonary disease;
- Definite history of neurological or psychiatric disorders, including epilepsy or dementia;
- History of drug abuse or alcohol use disorder;
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nanan Lv, M.D. contact
15 sites in 1 country
China15 sites
Affiliated Hospital of Hebei University
Baoding, Hebei
Yijuan Liang, hdfydbs@163.com
Yijuan Liang, M.M.
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality
Yue He, M.D., 86-010-85968407, yueyue870610@ccmu.edu.cn
Yue He, M.D.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Bin Li, 86-010-87788495, libin@cicams.ac.cn
Bin Li, M.D.
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yi Yang, M.D., 86-010-69154187, yangyi@pumch.cn
Yi Yang, M.D.
Peking University First Hospital
Beijing, Beijing Municipality
Jian Zhao, M.D., 86-010-69119025, 854496@qq.com
Jian Zhao, M.D.
The Second Hospital of Jilin University
Changchun, Jilin
Tianmin Xu, M.D., xutianmin@126.com
Tianmin Xu, M.D.
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
86-023-65303082, cqszlyy@163.com
Dongling Zou, M.D.
The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
Chongqing, Chongqing Municipality
Yanzhou Wang, M.D.
Yanzhou Wang, M.D.
Dalian Maternal and Child Health Hospital
Dalian
Lu Han
Lu Han, M.D.
Qilu Hospital of Shandong University
Jinan, Shandong
Youzhong Zhang, M.D., 86-0531-82169135, zhangyouzhong@vip.sina.com
Youzhong Zhang, M.D.
Gansu Provincial Maternity and Child-care Hospital / Gansu Provincial central Hospital
Lanzhou, Gansu
Ru lin, M.M.
Ru Lin, M.M.
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu
Boqun Xu, M.D., 86-025-52226919
86-023-65303082, cqszlyy@163.com
Shanxi Maternal and Child Health Hospital
Taiyuan, Shanxi
Xiaoli Li, M.D., 86-0351-3360320, Xiaoli-010@163.com
86-023-65303082, cqszlyy@163.com
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Ruifang An, M.D., 86-029-85323473
Ruifang An, M.D.
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Hui Chen, M.D., 86-0371-63930334
86-023-65303082, cqszlyy@163.com
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- NWRD09 Injection, NWRD09 Placebo
- Keywords
- NWRD09, mRNA Vaccine, HPV16-related cervical HSIL
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWRD09 InjectionBiological
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
NWRD09 PlaceboBiological
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
| Study group | Role | What they receive |
|---|---|---|
| 10 ug NWRD09 | Experimental | Not described Receives: Biological: NWRD09 Injection |
| 20 ug NWRD09 | Experimental | Not described Receives: Biological: NWRD09 Injection |
| Placebo for the 10 ug NWRD09 arm | Placebo comparator | Not described Receives: Biological: NWRD09 Placebo |
| Placebo for the 20 ug NWRD09 arm | Placebo comparator | Not described Receives: Biological: NWRD09 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
The number of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to CIN 1 or no lesions at the 24 week visit.
Measured: Week24
Secondary outcomes (15)
Incidence and severity of local and systemic adverse events (AEs).
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.
Measured: Up to week 64
Incidence and severity of all serious adverse events (SAEs).
Incidence and severity of all serious adverse events (SAEs) during the study period (e.g., suspected unexpected serious adverse reactions, unexpected adverse device effects).
Measured: Up to week 64
Pregnancy occurrences and outcomes during the study period.
Pregnancy occurrences and outcomes during the study period
Measured: Up to week 64
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Incidence of AEs leading to discontinuation of study treatment that are related to the investigational product.
Measured: Up to week 64
Proportion of Participants with Histopathological Regression of Cervical Lesions to no lesions.
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to no lesions at the 24 week visit.
Measured: Week 24
Proportion of Participants with Histopathological regression of Cervical Lesions to LSIL/CIN1.
Proportion of participants with histopathologically confirmed CIN2/3 whose cervical lesions regress to LSIL/CIN1 at the 24 week visit.
Measured: Week 24
Proportion of Participants with Virologically-proven Clearance of HPV 16.
Proportion of participants with virologically-proven clearance of HPV16 on cervical genotyping at week 24 visit.
Measured: 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.
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.
Measured: Week 24
Proportion of Participants with Histopathological Regression of Cervical Lesions to no Lesion and with Virologically-proven Clearance of HPV 16.
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.
Measured: Week 24
Proportion of Participants with Histopathological Regression to non-HSIL (LSIL/CIN1 or no lesion) in Participants with Baseline HPV16-only Infection.
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.
Measured: Week 24
Proportion of Participants with Histopathological Regression to no Lesion in Participants with Baseline HPV16-only Infection.
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.
Measured: Week 24
Proportion of Participants with Virologically-proven Clearance of Both HPV16 and non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
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.
Measured: Week 24
Proportion of Participants with Virologically-proven Clearance of non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
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.
Measured: Week 24
Levels of cellular immune responses.
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.
Measured: Weeks 4, 8, 16, 24 and 48
Levels of serum anti-HPV16 antibody titers.
Levels of serum anti-HPV16 antibody titers measured in peripheral blood samples collected at baseline and at Weeks 4, 8, 16, 24 and 48.
Measured: Weeks 4, 8, 16, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Squamous Intraepithelial Lesion (HSIL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712692
- Sponsor's protocol ID
- NWRD09-202
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07712692
- Acronym / sponsor ID
- NWRD09-202
- Keywords
- NWRD09, mRNA Vaccine, HPV16-related cervical HSIL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 10 ug NWRD09 | Experimental | Biological: NWRD09 Injection |
| 20 ug NWRD09 | Experimental | Biological: NWRD09 Injection |
| Placebo for the 10 ug NWRD09 arm | Placebo comparator | Biological: NWRD09 Placebo |
| Placebo for the 20 ug NWRD09 arm | Placebo comparator | Biological: NWRD09 Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years (inclusive), female;
- Confirmed by the central laboratory: histopathologically diagnosed cervical high-grade squamous intraepithelial lesion (HSIL) and HPV genotyping positive for HPV16;
- 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:
- Hematology: hemoglobin (Hb) ≥ 100 g/L; platelet count (PLT) ≥ 75 × 10⁹/L; absoluteneutrophil count ≥ 1.8 × 10⁹/L;
Key exclusion criteria (24 listed)
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), vulvar, vaginal, or anal high-grade intraepithelial lesions, or invasive cancer;
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period;
- Participation in another clinical trial within 30 days prior to screening, or currently being in the follow-up period of another clinical trial;
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NWRD09 InjectionNWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12. | Biological | 10 ug NWRD09, 20 ug NWRD09 |
| NWRD09 PlaceboPlacebo administered by intramuscular injection at weeks 0, 2, 4, and 12. | Biological | Placebo for the 10 ug NWRD09 arm, Placebo for the 20 ug NWRD09 arm |
Primary outcome
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24.
Time frame: 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.
15 secondary outcomes
Incidence and severity of local and systemic adverse events (AEs).
Time frame: Up to week 64
Incidence and severity of all serious adverse events (SAEs).
Time frame: Up to week 64
Pregnancy occurrences and outcomes during the study period.
Time frame: Up to week 64
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Time frame: Up to week 64
Proportion of Participants with Histopathological Regression of Cervical Lesions to no lesions.
Time frame: Week 24
Proportion of Participants with Histopathological regression of Cervical Lesions to LSIL/CIN1.
Time frame: Week 24
Proportion of Participants with Virologically-proven Clearance of HPV 16.
Time frame: 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.
Time frame: Week 24
Proportion of Participants with Histopathological Regression of Cervical Lesions to no Lesion and with Virologically-proven Clearance of HPV 16.
Time frame: Week 24
Proportion of Participants with Histopathological Regression to non-HSIL (LSIL/CIN1 or no lesion) in Participants with Baseline HPV16-only Infection.
Time frame: Week 24
Proportion of Participants with Histopathological Regression to no Lesion in Participants with Baseline HPV16-only Infection.
Time frame: Week 24
Proportion of Participants with Virologically-proven Clearance of Both HPV16 and non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
Time frame: Week 24
Proportion of Participants with Virologically-proven Clearance of non-HPV16 in Participants with Baseline Co-infection with non-HPV16.
Time frame: Week 24
Levels of cellular immune responses.
Time frame: Weeks 4, 8, 16, 24 and 48
Levels of serum anti-HPV16 antibody titers.
Time frame: Weeks 4, 8, 16, 24 and 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nanan Lv, M.D. contact
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NWRD09 Injection in people with High-grade Squamous Intraepithelial Lesion (HSIL), run by Newish Biotech (Wuxi) Co., Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Li, M.D. (86-010-87788495, libin@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants with Histopathological Regression of Cervical Lesions to non-HSIL (LSIL/CIN1 or no lesion) at week 24. (time frame: Week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.