High-grade Squamous Intraepithelial Lesion (HSIL)Phase 1NCT07047989
NWRD09 for HPV-16 Related Cervical HSIL
A Phase 1 study testing NWRD09 injection in people with High-grade Squamous Intraepithelial Lesion (HSIL), run by Newish Biotech (Wuxi) Co., Ltd. at 1 site in China.
Trial summary
This is a single-arm, open label, multi-center clinical study to evaluate the safety, tolerability and immunogenicity HPV16 targeted mRNA therapeutic vaccine (NWRD09) in HPV16 related cervical high-grade squamous intraepithelial lesions (HSlL). 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?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2025to 31 Dec 2026
- Phase
- Phase 1
- 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
- Patients had to meet all of the following inclusion criteria:
- Women aged between 18 and 65 years.
- HPV16-positive patients with histologically confirmed cervical HSlL.
- Colposcopic examination should be adequate, enabling clear visualization of the entire squamocolumnar junction(SCJ), as well as the full extent of acetowhite staining or suspected cervical intraepithelial neoplasia (ClN) lesions, including the upper boundary of the lesion.
- Major organ functions were normal within 1 week before the first NWRD09 administration: 1) Blood routine: Hemoglobin (Hb) ≥100 g/L; Platelet count (PLT) ≥75×109/L; 2) The liver: Total bilirubin (TB) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Plasma albumin ≥30 g/L; 3)Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥40mL/min (Cockcroft-Gault);
- For premenopausal women of child bearing potential, a blood pregnancy test must yield a negative result within 7 days prior to the first administration of the investigational drug; eligible subjects with reproductive capacity, as well as their spouses/partners, must agree to use effective contraceptive measures during the trial period or for at least 6 month safter the end-of-study visit (Week 24).
- Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.
Who cannot join
- Patients with any of the following were excluded from the study:
- Any histologically confirmed adenocarcinoma or adenocarcinoma in situ (AIS) or invasive cancer.
- Pregnant, breastfeeding, or planning to conceive during the study period.
- Participated in another clinical trial or is in the observation period of another clinical trial within 30 days prior to screening.
- Continuous (more than 1 week) use of corticosteroids (equivalent to >10 mg/day of prednisone) within 30 days prior to screening, except for hormone replacement therapy and local administration such as inhaled or ocular treatments.
- Continuous (more than 1 week) use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and anti-lymphocyte globulin) within 30 days prior to screening.
Show all 19Show fewer
- Received any non-live/live vaccine injection within 4 weeks prior to the first dose of NWRD09.
- Any history of therapeutic HPV vaccination (previously approved preventive HPV vaccination is acceptable).
- Received treatment HSIL within 4 weeks prior to the first dose of NWRD09.
- Prohibited: Use of blood/blood-derived products (e.g., immunoglobulins) within 3 months before first dose or intended use during the study.
- History of immunodeficiency or autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis).
- Current or anticipated use of disease-modifying antirheumatic drugs (e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) and biological agents (e.g., infliximab, adalimumab, etanercept) during the study.
- History of solid organ or bone marrow transplantation.
- Past or current malignancies, except for adequately treated and completely cured ductal carcinoma in situ of the breast, basal cell carcinoma of the skin, superficial bladder tumors, or any other malignancies cured more than 5 years before entering the study.
- Uncontrolled severe infections (>Grade 2 NCI-CTCAE adverse events, version 5.0).
- Patients who test positive for any of the following: hepatitis C virus (HCV)antibody, human immunodeficiency virus (HlV) antibody, or syphilis treponema antibody; except those with abnormal hepatitis B serology (i.e., positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]) but meet one of the following criteria:
- 1)HBV-DNA ≤2,500 copies/mL or ≤ 500lU/mL, or 2)HBV-DNA within the normal reference range of the testing center. 16.History of severe or multiple hypersensitivity to drugs or pharmaceutical preparations.
- 17.Severe dysfunction of other organs or heart and lung diseases. 18.History of definite neurological or psychiatric disorders, including epilepsy or dementia.
- 19.History of drug abuse or alcoholism. 20.Patients deemed unsuitable to participate in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Fang Jinag, 86-010-69155635, 13671170943@163.com
About this study
Official title: Safety, Tolerability and Immunogenicity Study of NWRD09 in HPV16 Related Cervical High-grade Squamous Intraepithelial Lesions (HSlL)
This is a single-arm, open label, multi-center clinical study to evaluate the safety, tolerability and immunogenicity HPV16 targeted mRNA therapeutic vaccine (NWRD09) in HPV16 related cervical high-grade squamous intraepithelial lesions (HSlL).
Read the detailed description
This study is divided into three dose groups. Each patient will be administered NWRD09 by intramuscular injection at week 0,2,4 and12. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
The subjects shall continue to receive safety follow-up until 28 days after the third administration. Colposcopy and biopsy were performed at week 24.
This study will select 1-2 dose levels for subject expansion based on the dose escalation phase, to further evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in HPV16 related cervical HSIL patients.
- Being tested
- NWRD09 injection
- Keywords
- NWRD09, mRNA vaccine, HPV16, 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
| Study group | Role | What they receive |
|---|---|---|
| Dose1-3 of NWRD09 | Experimental | Patients will be assigned to three dose groups. Each patient will be administered NWRD09 by intramuscular injection. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. Receives: Biological: NWRD09 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events).
Measured: To week 24
Dose-limiting toxicity (DLT)
It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the third dosing will be classified as DLT during dosing climb.
Measured: Within 28 days of the third dosing
Secondary outcomes (3)
Immunogenicity
Immunologic reactogenicity by measuring HPV16 specific T cell response (IFN-γ ELISPOT) and anti HPV16 antibodies (ELISA) in blood samples
Measured: Week 4、8、16、24、48
Histopathology outcome and HPV Viral clearance
Number of subjects with virologically-proven clearance of HPV 16 and number of subjects with histopathological regression of cervical lesions to CIN 1 or normal
Measured: Week 24.
The recommended phase II dose (RP2D)
The recommended phase II dose (RP2D) was selected on the basis of tolerability during the safety expansion.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start12 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 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
- NCT07047989
- Sponsor's protocol ID
- NWRD09-102
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Immunogenicity Study of NWRD09 in HPV16 Related Cervical High-grade Squamous Intraepithelial Lesions (HSlL)
- ClinicalTrials.gov ID
- NCT07047989
- Acronym / sponsor ID
- NWRD09-102
- Keywords
- NWRD09, mRNA vaccine, HPV16, HSIL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Jul 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 single-arm, open label, multi-center clinical study to evaluate the safety, tolerability and immunogenicity HPV16 targeted mRNA therapeutic vaccine (NWRD09) in HPV16 related cervical high-grade squamous intraepithelial lesions (HSlL).
Detailed description
This study is divided into three dose groups. Each patient will be administered NWRD09 by intramuscular injection at week 0,2,4 and12. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
The subjects shall continue to receive safety follow-up until 28 days after the third administration. Colposcopy and biopsy were performed at week 24.
This study will select 1-2 dose levels for subject expansion based on the dose escalation phase, to further evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in HPV16 related cervical HSIL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose1-3 of NWRD09 | Experimental | Biological: NWRD09 injectionPatients will be assigned to three dose groups. Each patient will be administered NWRD09 by intramuscular injection. The Maximum Tolerated Dose of NWRD09 will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged between 18 and 65 years.
- HPV16-positive patients with histologically confirmed cervical HSlL.
- Colposcopic examination should be adequate, enabling clear visualization of the entire squamocolumnar junction(SCJ), as well as the full extent of acetowhite staining or suspected cervical intraepithelial neoplasia (ClN) lesions, including the upper boundary of the lesion.
- Major organ functions were normal within 1 week before the first NWRD09 administration: 1) Blood routine: Hemoglobin (Hb) ≥100 g/L; Platelet count (PLT) ≥75×109/L; 2) The liver: Total bilirubin (TB) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Plasma albumin ≥30 g/L; 3)Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥40mL/min (Cockcroft-Gault);
- For premenopausal women of child bearing potential, a blood pregnancy test must yield a negative result within 7 days prior to the first administration of the investigational drug; eligible subjects with reproductive capacity, as well as their spouses/partners, must agree to use effective contraceptive measures during the trial period or for at least 6 month safter the end-of-study visit (Week 24).
Key exclusion criteria (19 listed)
- Any histologically confirmed adenocarcinoma or adenocarcinoma in situ (AIS) or invasive cancer.
- Pregnant, breastfeeding, or planning to conceive during the study period.
- Participated in another clinical trial or is in the observation period of another clinical trial within 30 days prior to screening.
- Continuous (more than 1 week) use of corticosteroids (equivalent to >10 mg/day of prednisone) within 30 days prior to screening, except for hormone replacement therapy and local administration such as inhaled or ocular treatments.
- Continuous (more than 1 week) use of immunosuppressants (e.g., cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, and anti-lymphocyte globulin) 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 | Biological | Dose1-3 of NWRD09 |
Primary outcome
Safety
Time frame: To week 24
All adverse events (AE) will be determined based on the rate and severity grade of events, including incidence and severity of serious adverse events (SAE) (according to NCI-CTCAE Standard version 5.0 of common Terms for Adverse Events).
Dose-limiting toxicity (DLT)
Time frame: Within 28 days of the third dosing
It would be determined based on the rate and severity grade of events or abnormalities through evaluating systemic or local adverse events, clinical laboratory test results, vital signs that is definitely, probably, or possibly related to the test drug occurring within 28 days of the third dosing will be classified as DLT during dosing climb.
3 secondary outcomes
Immunogenicity
Time frame: Week 4、8、16、24、48
Histopathology outcome and HPV Viral clearance
Time frame: Week 24.
The recommended phase II dose (RP2D)
Time frame: Week 24
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 2 Jul 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NWRD09 injection in people with High-grade Squamous Intraepithelial Lesion (HSIL), run by Newish Biotech (Wuxi) Co., Ltd. at 1 site 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 7 inclusion and 19 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 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 (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?
Safety (time frame: To week 24). The study lists 2 primary outcomes in all. 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 2 Jul 2025.