High-grade Squamous Intraepithelial Lesion (HSIL)Phase 2NCT07175662
Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
A Phase 2 study testing NWRD08 administered by electroporation in people with High-grade Squamous Intraepithelial Lesion (HSIL), run by Newish Biotech (Wuxi) Co., Ltd. at 5 sites in China.
Trial summary
This is a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- High-grade Squamous Intraepithelial Lesion (HSIL)
- What is being tested?
- NWRD08 administered by electroporation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 5 sitesChina
- Study dates
- 11 Nov 2025to 30 Aug 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects had to meet all of the following inclusion criteria:
- 1. Aged 18 to 60 years, female.
- 2. Confirmed by the central laboratory, histopathology results demonstrated cervical HSIL with concurrent HPV16 and/or HPV18 positivity.
- 3. Colposcopy results during screening must meet the following criteria:
- The colposcopy must be satisfactory, allowing clear visualization of the entire acetowhite area or the extent of suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper border of the lesion.
- If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
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- The cervical lesion area must be less than 75% of the surface of the ectocervix.
- 4. Fully understand the study and voluntarily sign the informed consent form, able to communicate well with the investigator and complete all treatments, examinations, and visits as required by the study protocol. The informed consent form must be signed before performing any study-specific procedures.
- 5. At screening, the investigator judges the electrocardiogram (ECG) as normal or without clinically significant findings.
- 6. Normal function of major organs within 1 week before the first dose: Blood routine: Hemoglobin (Hb) ≥100 g/L; platelet count (PLT) ≥75×10⁹/L; white blood cell count (WBC) ≥3.0×10⁹/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L.
- Liver: Total bilirubin (TB) ≤1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; plasma albumin ≥30 g/L.
- Kidney: Serum creatinine (Scr) ≤1.5 × ULN, or creatinine clearance rate ≥60 mL/min (calculated by Cockcroft-Gault formula) (if serum creatinine >1.5 × ULN).
- 7. Women of childbearing potential must be willing to consistently and correctly use a contraceptive method with a failure rate of less than 1% per year from the time of signing the informed consent form until the end of the study. Acceptable methods include:
- Hormonal contraceptives: Combined or progestin-only methods, including oral contraceptives, injections, implants, vaginal rings, or transdermal patches. Subjects with a history of hypercoagulable states (e.g., deep vein thrombosis, pulmonary embolism) must not use hormonal contraceptives.
- Abstinence from penile-vaginal intercourse.
- Intrauterine device (IUD) or intrauterine system (IUS).
- Female subject's male partner sterilized for at least 6 months prior to study entry, and this male is the subject's sole sexual partner.
- Condom use, with emergency contraception required in case of accidents such as slippage or breakage.
- Postmenopausal patients (defined as at least 12 consecutive months of amenorrhea without alternative medical causes, with serum follicle-stimulating hormone levels within the laboratory reference range for postmenopausal women) or those sterilized for more than 12 months prior to screening may be considered not requiring contraception.
Who cannot join
- Patients with any of the following were excluded from the study:
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Administration 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.
- Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
- Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before screening.
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- Treatment for cervical HSIL within 4 weeks prior to the first dose.
- Presence of metal implants or implantable medical devices within the electroporation area.
- Participation in another clinical trial within 30 days prior to screening or being in the follow-up period of another clinical trial.
- Continuous (for more than 1 week) systemic treatment with corticosteroids (at a dose equivalent to >10 mg/day prednisone or equivalent doses of other corticosteroids) or other immunosuppressive drugs within 30 days prior to screening, with the following exceptions.
- Inhaled, ophthalmic, or topical use of corticosteroids at doses ≤10 mg/day prednisone or equivalent is permitted.
- Physiological corticosteroid replacement therapy at doses ≤10 mg/day prednisone or equivalent is permitted.
- History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, etc.) or current active autoimmune diseases requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs).
- Current or anticipated use of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biologic disease-modifying drugs (e.g., infliximab, adalimumab, etanercept) during the study.
- Continuous (for more than 1 week) use of immunosuppressants such as cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and antilymphocyte globulin, as well as other inhibitors affecting immune function (e.g., IL-6 inhibitors, TNF inhibitors, IL-17/23 inhibitors, JAK inhibitors) within 30 days prior to screening.
- History of solid organ or bone marrow transplantation.
- Active infections requiring systemic treatment (including active tuberculosis, active Treponema pallidum infection, and bacterial, fungal, or viral infections requiring systemic therapy).
- Positive test results for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (anti-HIV).
- Participants with active herpes zoster virus infection.
- Participants with severe dysfunction of other organs or cardiopulmonary diseases.
- Epilepsy requiring medication (e.g., steroids or antiepileptic drugs).
- History or current diagnosis of malignancy.
- History of severe allergies, allergic diseases, or allergic constitution, meeting any of these criteria.
- Evidence or history of clinically significant cardiac disease, including but not limited to:
- 1) Congestive heart failure (NYHA Class >2). 2) Unstable angina. 3) Myocardial infarction within the past 3 months. 4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention.
- 5) QTc interval ≥470 ms. 6) Poorly controlled hypertension (defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg while on antihypertensive medication).
- 22. Known psychiatric or substance abuse disorders that may interfere with the subject's ability to comply with study requirements.
- 23. History or current evidence of any condition, treatment, laboratory abnormality, or other circumstance that may increase the risk associated with study participation or study intervention administration, or may interfere with the interpretation of study results, and which, in the investigator's judgment, makes the subject unsuitable for enrollment in this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Bin Li, M.D., lb87960440@vip.sina.com, lb87960440@vip.sina.com
- Recruiting
Beijing Obstetrics and Gynecology Hospital
Beijing, Beijing Municipality, 100026
Yue He, M.D., yueyue870610@ccmu.edu.cn, yueyue870610@ccmu.edu.cn
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jian Zhao, M.D., 854496@qq.com, 854496@qq.com
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Fang Jiang, M.D., 86-010-6915-5635, 13671170934@163.cn
- Recruiting
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Wei Wang, M.D., 36891768@qq.com, 36891768@qq.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of NWRD08 in Patients With HPV16/18-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 NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) 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 and/or HPV18.
Read the detailed description
This is a Phase II, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD08 in patients with HPV16 and/or HPV18 positive cervical high-grade squamous intraepithelial lesion (HSIL). Eligible subjects will be randomized in a 2:2:1:1 ratio to four arms: 2 mg NWRD08, 4 mg NWRD08, and their respective matching placebo arms.
Participants will receive intramuscular injections of either NWRD08 or matching placebo at the corresponding dose at Week0, 4, 8, and 16 (a total of 4 doses).
Efficacy evaluations at Week 36 will include colposcopy, histopathological biopsy, cervical cytology, and HPV testing.
- Being tested
- NWRD08 administered by electroporation, Placebo administered by electroporation
- Keywords
- cervical HSIL, NWRD08, HPV16, HPV18
- 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.
NWRD08 administered by electroporationBiological
NWRD08 delivered via IM injection + electroporation using TERESA device
Placebo administered by electroporationBiological
Placebo delivered via IM injection + electroporation using TERESA device
| Study group | Role | What they receive |
|---|---|---|
| 2mg NWRD08 | Experimental | Each patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16. Receives: Biological: NWRD08 administered by electroporation |
| 4mg NWRD08 | Experimental | Each patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16. Receives: Biological: NWRD08 administered by electroporation |
| Placebo for the 2 mg NWRD08 arm | Placebo comparator | Each patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16. Receives: Biological: Placebo administered by electroporation |
| Placebo for the 4 mg NWRD08 arm | Placebo comparator | Each patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16. Receives: Biological: Placebo administered by electroporation |
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 CIN 1 or no lesions at week 36
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or no lesions at the 36 week visit.
Measured: Week 36
Secondary outcomes (14)
Incidence and severity of local and systemic adverse events (AEs).
Adverse events (AEs) and serious adverse events (SAEs) will be monitored based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Measured: up to 40 weeks
Incidence and severity of adverse events (AEs) at the injection site.
Adverse events (AEs) and serious adverse events (SAEs) will be monitored based on the Guidance on Grading Standards for Adverse Events in Clinical Trials of Preventive Vaccines.
Measured: up to 40 weeks
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 40 weeks
Pregnancy occurrences and outcomes during the study period
Measured: up to 40 weeks
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Measured: up to 40 weeks
Incidence of Grade 3 or higher adverse events (AEs) related to the investigational product.
Measured: up to 40 weeks
Proportion of Participants with Histopathological Regression to no lesions.
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to no lesions at the 36 week visit.
Measured: Week 36
Proportion of Participants with Histopathological Regression to LSIL/CIN1.
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to LSIL/CIN1 at the 36 week visit.
Measured: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 and/or HPV18.
The number of participants with virologically-proven clearance of HPV16 and/or HPV18 at the 36 week visit.
Measured: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 or HPV18 or Histopathological Regression of Cervical Lesions to LSIL/CIN 1 or no lesion.
The number of participants with Virologically-proven Clearance of HPV 16 or HPV18 or Histopathological Regression of Cervical Lesions to LSIL/CIN 1 or no lesion at the 36 week visit.
Measured: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 or HPV18 in Combination with Histopathological Regression of Cervical Lesions to LSIL/CIN 1 or no lesion.
The number of participants with Virologically-proven Clearance of HPV 16 or HPV18 in Combination with Histopathological Regression of Cervical Lesions to LSIL/CIN 1 or no lesion at the 36 week visit.
Measured: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 or HPV18 in Combination with Histopathological Regression of Cervical Lesions to no lesion.
The number of participants with Virologically-proven Clearance of HPV 16 or HPV18 in Combination with Histopathological Regression of Cervical Lesions to no lesion at the 36 week visit.
Measured: Week 36
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 Week 10, 18, 24, and 36 after first dose.
Measured: Week 10, 18, 24, and 36
Levels of serum anti-HPV16 and anti-HPV18 antibody titers.
Levels of serum anti-HPV16 and anti-HPV18 antibody titers measured in peripheral blood samples collected at baseline and at Week 10, 18, 24, and 36 after initial vaccination.
Measured: Week 10, 18, 24, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start11 Nov 2025
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 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
- 150 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
- NCT07175662
- Sponsor's protocol ID
- NWRD08-201
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 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 NWRD08 in Patients With HPV16/18-Positive Cervical High-Grade Squamous Intraepithelial Lesion (HSIL)
- ClinicalTrials.gov ID
- NCT07175662
- Acronym / sponsor ID
- NWRD08-201
- Keywords
- cervical HSIL, NWRD08, HPV16, HPV18
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 16 Sep 2025 (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 NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) 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 and/or HPV18.
Detailed description
This is a Phase II, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of NWRD08 in patients with HPV16 and/or HPV18 positive cervical high-grade squamous intraepithelial lesion (HSIL). Eligible subjects will be randomized in a 2:2:1:1 ratio to four arms: 2 mg NWRD08, 4 mg NWRD08, and their respective matching placebo arms.
Participants will receive intramuscular injections of either NWRD08 or matching placebo at the corresponding dose at Week0, 4, 8, and 16 (a total of 4 doses).
Efficacy evaluations at Week 36 will include colposcopy, histopathological biopsy, cervical cytology, 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 |
|---|---|---|
| 2mg NWRD08 | Experimental | Biological: NWRD08 administered by electroporationEach patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16. |
| 4mg NWRD08 | Experimental | Biological: NWRD08 administered by electroporationEach patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16. |
| Placebo for the 2 mg NWRD08 arm | Placebo comparator | Biological: Placebo administered by electroporationEach patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16. |
| Placebo for the 4 mg NWRD08 arm | Placebo comparator | Biological: Placebo administered by electroporationEach patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- 1. Aged 18 to 60 years, female.
- 2. Confirmed by the central laboratory, histopathology results demonstrated cervical HSIL with concurrent HPV16 and/or HPV18 positivity.
- The colposcopy must be satisfactory, allowing clear visualization of the entire acetowhite area or the extent of suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper border of the lesion.
- If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
- The cervical lesion area must be less than 75% of the surface of the ectocervix.
Key exclusion criteria (28 listed)
- Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Administration 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.
- Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
- Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before 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 |
|---|---|---|
| NWRD08 administered by electroporationNWRD08 delivered via IM injection + electroporation using TERESA device | Biological | 2mg NWRD08, 4mg NWRD08 |
| Placebo administered by electroporationPlacebo delivered via IM injection + electroporation using TERESA device | Biological | Placebo for the 2 mg NWRD08 arm, Placebo for the 4 mg NWRD08 arm |
Primary outcome
Proportion of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or no lesions at week 36
Time frame: Week 36
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or no lesions at the 36 week visit.
14 secondary outcomes
Incidence and severity of local and systemic adverse events (AEs).
Time frame: up to 40 weeks
Incidence and severity of adverse events (AEs) at the injection site.
Time frame: up to 40 weeks
Incidence and severity of all serious adverse events (SAEs).
Time frame: up to 40 weeks
Pregnancy occurrences and outcomes during the study period
Time frame: up to 40 weeks
Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.
Time frame: up to 40 weeks
Incidence of Grade 3 or higher adverse events (AEs) related to the investigational product.
Time frame: up to 40 weeks
Proportion of Participants with Histopathological Regression to no lesions.
Time frame: Week 36
Proportion of Participants with Histopathological Regression to LSIL/CIN1.
Time frame: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 and/or HPV18.
Time frame: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 or HPV18 or Histopathological Regression of Cervical Lesions to LSIL/CIN 1 or no lesion.
Time frame: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 or HPV18 in Combination with Histopathological Regression of Cervical Lesions to LSIL/CIN 1 or no lesion.
Time frame: Week 36
Proportion of Participants with Virologically-proven Clearance of HPV 16 or HPV18 in Combination with Histopathological Regression of Cervical Lesions to no lesion.
Time frame: Week 36
Levels of cellular immune responses.
Time frame: Week 10, 18, 24, and 36
Levels of serum anti-HPV16 and anti-HPV18 antibody titers.
Time frame: Week 10, 18, 24, and 36
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 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 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 NWRD08 administered by electroporation in people with High-grade Squamous Intraepithelial Lesion (HSIL), run by Newish Biotech (Wuxi) Co., Ltd. at 5 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 19 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 Yang Xiang, M.D. (+86-010-69155635, xiangy@pumch.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 CIN 1 or no lesions at week 36 (time frame: Week 36). 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 Feb 2026.