A Phase 2 interventional study of NWRD09 Injection and NWRD09 Placebo in High-grade Squamous Intraepithelial Lesion (HSIL), sponsored by Newish Biotech (Wuxi) Co., Ltd.. Not yet recruiting at 15 sites in China. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Newish Biotech (Wuxi) Co., Ltd. · Phase 2, Interventional, and Treatment
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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.
Among the 26 studies in Squamous Intraepithelial Lesions with a site in China, this one is the 7th largest by planned enrollment of the 14 interventional ones that give a count, is one of 4 that started in 2026, is one of 4 in phase 2, reaches primary completion later than 14 of the 17 other live ones, and was the 26th registered.
104 studies on the registry are indexed under Squamous Intraepithelial Lesions; 36 are open to participants now.
Browse Squamous Intraepithelial Lesions studies →17 of the 26 studies in Squamous Intraepithelial Lesions with a site in China are open now. Recruiting first, the newest first:
Second Affiliated Hospital, Zhejiang University, School of Medicine · Sites in China
Ages 25–65 · Women only · Healthy volunteers
Second Affiliated Hospital, Zhejiang University, School of Medicine · Sites in China
Ages 20–60 · Women only · Healthy volunteers
Newish Biotech (Wuxi) Co., Ltd. · Sites in China
Ages 18–60 · Women only
Newish Biotech (Wuxi) Co., Ltd. · Sites in China
Ages 18–65 · Women only
First Affiliated Hospital of Wenzhou Medical University · Sites in China
Ages 18–65 · Women only
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 →
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 65 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
26 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 156 is above the median of 71 across 73 interventional studies indexed under Squamous Intraepithelial Lesions.
Median enrollment 153 across the 14 interventional studies, 1,000 across the 12 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
6 of 26 have an industry lead sponsor. The 10 most frequent:
Newish Biotech (Wuxi) Co., Ltd. is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Newish Biotech (Wuxi) Co., Ltd. has 4 studies filed under Squamous Intraepithelial Lesions — fewer than ten, so there is no comparison to draw.
3 of the studies in Squamous Intraepithelial Lesions with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07306247Second Affiliated Hospital, Zhejiang University, School of MedicineMulticenter Prospective Non-randomized Controlled Study of ALA-PDT for LSIL With HPV16/18 Infection | 2027-01 |
| NCT07175662Newish Biotech (Wuxi) Co., Ltd.Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL | 2027-05-30 |
| NCT07712692Newish Biotech (Wuxi) Co., Ltd.Evaluation of NWRD09 for HPV-16 Related Cervical HSIL | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 26 studies in Squamous Intraepithelial Lesions with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
Participants had to meet all of the following inclusion 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:
Exclusion Criteria:
Participants with any of the following were excluded from the study:
Continuous use (for more than 1 week) of systemic therapy (at a dose equivalent to >10 mg/day prednisone or equivalent dose of other glucocorticoids) or other agents within 30 days prior to screening, except for the following:
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: NWRD09 Injection
Biological: NWRD09 Injection
Biological: NWRD09 Placebo
Biological: NWRD09 Placebo
NWRD09 administered by intramuscular injection at weeks 0, 2, 4, and 12.
Placebo administered by intramuscular injection at weeks 0, 2, 4, and 12.
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.
Time frame: Week24
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.
Time frame: 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).
Time frame: Up to week 64
Pregnancy occurrences and outcomes during the study period.
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.
Incidence of AEs leading to discontinuation of study treatment that are related to the investigational product.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
Time frame: 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.
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.
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.
Time frame: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 4, 8, 16, 24 and 48
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol
Time frame: 6 months after publication
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: NWRD09
Squamous Intraepithelial Lesions →
Newish Biotech (Wuxi) Co., Ltd. →