ClinicalTrials.gg
RecruitingNCT07175662Updated Feb 17, 2026

Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL

A Phase 2 interventional study of NWRD08 administered by electroporation and Placebo administered by electroporation in High-grade Squamous Intraepithelial Lesion (HSIL), sponsored by Newish Biotech (Wuxi) Co., Ltd.. Recruiting at 5 sites in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Newish Biotech (Wuxi) Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.

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Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 26 studies in Squamous Intraepithelial Lesions with a site in China — 17 open to participants now, 18 under way, none of them phase 3. Squamous Intraepithelial Lesions · China.

Planned enrollment
8th of 14
150 · median 153
Started
2025
with 2 others
Phase 2
4 of 26
3 open now
Primary completion
2027-05
later than 13 of 17 live
Registered
21st of 26
by date
Lead sponsor
3 of 26
Newish Biotech (Wuxi) Co., Ltd.

Among the 26 studies in Squamous Intraepithelial Lesions with a site in China, this one is the 8th largest by planned enrollment of the 14 interventional ones that give a count, is one of 3 that started in 2025, is one of 4 in phase 2, reaches primary completion later than 13 of the 17 other live ones, and was the 21st registered.

Squamous Intraepithelial Lesions

104 studies on the registry are indexed under Squamous Intraepithelial Lesions; 36 are open to participants now.

Browse Squamous Intraepithelial Lesions studies →

Open to participants now

17 of the 26 studies in Squamous Intraepithelial Lesions with a site in China are open now. Recruiting first, the newest first:

11 more — sign in →

All 17 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 23 Squamous Intraepithelial Lesions studies recruiting now, 11 (48%) set no upper age limit and 11 (48%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 60 Years · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 26 studies in Squamous Intraepithelial Lesions with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • High-grade Squamous Intraepithelial Lesion (HSIL)

Keywords

  • cervical HSIL
  • NWRD08
  • HPV16
  • HPV18
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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:

  1. 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.
  2. If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
  3. The cervical lesion area must be less than 75% of the surface of the ectocervix.

4. Fully understand the study and voluntarily sign the 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 (ECG) as normal or without findings.

6. Normal function of major organs within 1 week before the first dose: Blood routine: (Hb) ≥100 g/L; count (PLT) ≥75×10⁹/L; white blood cell count (WBC) ≥3.0×10⁹/L; (ANC) ≥1.5×10⁹/L.

Liver: Total (TB) ≤1.5 × (ULN); (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; plasma albumin ≥30 g/L.

Kidney: Serum creatinine (Scr) ≤1.5 × ULN, or rate ≥60 mL/min (calculated by Cockcroft-Gault formula) (if serum creatinine >1.5 × ULN).

7. Women of must be willing to consistently and correctly use a 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:

  1. 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.
  2. Abstinence from penile-vaginal intercourse.
  3. Intrauterine device (IUD) or intrauterine system (IUS).
  4. 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.
  5. Condom use, with emergency contraception required in case of accidents such as slippage or breakage.
  6. 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.

Exclusion criteria

Exclusion Criteria:

Patients with any of the following were excluded from the study:

  1. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
  2. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
  3. Administration of any within 4 weeks prior to the first dose and/or any non-live vaccine within 2 weeks prior to the first dose.
  4. Use of blood or blood-related products (including immunoglobulins) within 3 months prior to the first dose or planned use during the study.
  5. Prior receipt of therapeutic HPV vaccines (excluding prophylactic HPV vaccines) before screening.
  6. Treatment for cervical HSIL within 4 weeks prior to the first dose.
  7. Presence of metal implants or implantable medical devices within the electroporation area.
  8. Participation in another clinical trial within 30 days prior to screening or being in the follow-up period of another clinical trial.
  9. Continuous (for more than 1 week) systemic treatment with (at a dose equivalent to >10 mg/day prednisone or equivalent doses of other corticosteroids) or other drugs within 30 days prior to screening, with the following exceptions.

    1. Inhaled, ophthalmic, or topical use of corticosteroids at doses ≤10 mg/day prednisone or equivalent is permitted.
    2. Physiological corticosteroid replacement therapy at doses ≤10 mg/day prednisone or equivalent is permitted.
  10. History of immunodeficiency or 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).
  11. 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.
  12. 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.
  13. History of solid organ or bone marrow transplantation.
  14. Active infections requiring systemic treatment (including active tuberculosis, active Treponema pallidum infection, and bacterial, fungal, or viral infections requiring systemic therapy).
  15. Positive test results for any of the following: surface antigen (HBsAg), virus antibody (anti-HCV), Treponema pallidum antibody (TP-Ab), or antibody (anti-HIV).
  16. Participants with active herpes zoster virus infection.
  17. Participants with severe dysfunction of other organs or cardiopulmonary diseases.
  18. Epilepsy requiring medication (e.g., steroids or antiepileptic drugs).
  19. History or current diagnosis of .
  20. History of severe allergies, allergic diseases, or allergic constitution, meeting any of these criteria.
  21. Evidence or history of cardiac disease, including but not limited to:

1) Congestive heart failure ( Class >2). 2) Unstable angina. 3) Myocardial infarction within the past 3 months. 4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention.

5) ≥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.

Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    2mg NWRD08

    Each patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16.

    Biological: NWRD08 administered by electroporation

  • Experimental
    4mg NWRD08

    Each patient will be administered NWRD08 by electroporation at Week0, 4, 8, and 16.

    Biological: NWRD08 administered by electroporation

  • Placebo comparator
    Placebo for the 2 mg NWRD08 arm

    Each patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16.

    Biological: Placebo administered by electroporation

  • Placebo comparator
    Placebo for the 4 mg NWRD08 arm

    Each patient will be administered Placebo control by electroporation at Week 0, 4, 8, and 16.

    Biological: Placebo administered by electroporation

Interventions

  • NWRD08 delivered via IM injection + electroporation using TERESA device

  • BiologicalPlacebo administered by electroporation

    Placebo delivered via IM injection + electroporation using TERESA device

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 36

Secondary outcomes

  1. 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.

    Time frame: up to 40 weeks

  2. 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.

    Time frame: up to 40 weeks

  3. 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).

    Time frame: up to 40 weeks

  4. Pregnancy occurrences and outcomes during the study period

    Time frame: up to 40 weeks

  5. Incidence of investigational product-related adverse events (AEs) leading to treatment discontinuation.

    Time frame: up to 40 weeks

  6. Incidence of Grade 3 or higher adverse events (AEs) related to the investigational product.

    Time frame: up to 40 weeks

  7. 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.

    Time frame: Week 36

  8. 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.

    Time frame: Week 36

  9. 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.

    Time frame: Week 36

  10. 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.

    Time frame: Week 36

  11. 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.

    Time frame: Week 36

  12. 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.

    Time frame: Week 36

  13. 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.

    Time frame: Week 10, 18, 24, and 36

  14. 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.

    Time frame: Week 10, 18, 24, and 36

07

Study locations

5 of 5 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2025 (actual). Primary completion is estimated for May 2027, 18 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2025
First posted
Sep 16, 2025
StartActual
Nov 11, 2025
Primary completionEst.
May 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Feb 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07175662
Responsible party
Sponsor
First posted
Sep 16, 2025
Start date
Nov 11, 2025
Primary completion
May 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Feb 17, 2026

Study contacts

Yang Xiang, M.D.
Contact
xiangy@pumch.cn
+86-010-69155635
Fang Jiang
Contact
13671170943@163.com
+86-010-69155635

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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