AzTrials
AzTrials

Intraepithelial NeoplasiaNCT07092007

NWRD09 for HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer

A study testing NWRD09 administered by intramuscular injection in people with Intraepithelial Neoplasia and Cervical Cancer, run by Newish Technology (Beijing) Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a single-arm, open label, two cohorts, multi-center clinical study to evaluate the safety and efficacy of HPV-16 targeted mRNA vaccine (NWRD09) in HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B). Read more about this study

Who is it for?
Ages 18 to 60 years, women only
Conditions the study is for
Intraepithelial Neoplasia, Cervical Cancer
What is being tested?
NWRD09 administered by intramuscular injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
5 Jun 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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

  • Patients had to meet all of the following inclusion criteria:
  • Women aged between 18 and 60 years.
  • HPV16 is positive during the screening period.
  • Histologically confirmed HPV-16-associated cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL). In the case of LSIL, it is necessary to meet persistent HPV16 infection for more than 6 months. In the case of HSIL, it is necessary to meet the requirements of satisfactory colposcopy at screening, which is defined as the squamous columnar epithelial junction (class I or class II transformation zone) is fully visible, and the upper limit of the white epithelium acetate or suspected CIN lesions are fully visible.
  • Eligible subjects of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partner for the duration of the trial or for at least 6 months after the last dose. For premenopausal women with the possibility of childbearing, blood pregnancy tests must be negative within 7 days prior to the first use of the NWRD09.
  • 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.
Show all 20Show fewer
  • Patients had to meet all of the following inclusion criteria:
  • Women aged ≥ 18 years.
  • HPV16-related recurrent or metastatic advanced cervical cancer (Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma) patients who have progressed after at least one lines of standard therapy or are intolerant to toxic side effects, or for which there is no standard treatment at present (Treatment failure refers to: disease progression during or after treatment with systemic antineoplastic regimens; Intolerance refers to: the patient has grade 3-4 adverse reactions after receiving standard therapy, and the patient refuses to continue the original treatment).
  • At least 1 measurable lesion (RECIST 1.1). Tumor lesions that have received prior radiotherapy or other local therapy are considered measurable only if disease progression at the treatment site is clearly documented after completion of treatment.
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
  • Had recovered from all toxicities related to prior anticancer therapies to grade≤1 or baseline level as defined by CTCAE v5.0 (except for the asymptomatic laboratory examination abnormalities such as elevated ALP, hyperuricemia, elevated serum amylase/lipase, elevated blood glucose, etc., and toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy, etc.).
  • Major organ functions must meet the following criteria:
  • Blood routine: absolute neutrophil count (ANC) ≥ 1.5×10^9/L, platelet count ≥ 80×10^9/L, hemoglobin ≥ 90 g/L,
  • Liver function: total bilirubin (TBIL) ≤ 1.5 ULN (≤ 3 ULN for Gilbert's syndrome, liver cancer, or liver metastases), AST and ALT ≤ 2.5 ULN for subjects without liver metastases, and ≤ 5.0 ULN for subjects with liver metastases,
  • Renal function: creatinine (Cr) ≤ 1.5 ULN, or creatinine clearance (Ccr) ≥ 50 mL/min (using the Cockcroft and Gault formula),
  • Coagulation function: international normalized ratio (INR) ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.
  • Has life expectancy of at least 3 months in the best judgement of the investigator.
  • Eligible subjects of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with their partner for the duration of the trial or for at least 6 months after the last dose. For premenopausal women with the possibility of childbearing, blood pregnancy tests must be negative within 7 days prior to the first use of the NWRD09.
  • 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 histopathologically confirmed adenocarcinoma or adenocarcinoma in situ (AIS) or invasive cancer.
  • Pregnant, breastfeeding, or planning to conceive during the study period.
  • Received any non-live vaccine injection within 2 weeks prior to the first dose of NWRD09.
  • Received any live vaccine injection within 4 weeks prior to the first dose of NWRD09.
  • Received treatment for LSIL or HSIL within 4 weeks prior to the first dose of NWRD09.
Show all 59Show fewer
  • 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.
  • 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).
  • 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.
  • 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).
  • History of HIV infection or syphilis carrier.
  • Active infection (e.g., acute bacterial infection, tuberculosis, active syphilis, active phase of herpes zoster virus infection, active hepatitis B or C, etc.).
  • ① Active hepatitis C is defined as: positive hepatitis C antibody and HCV-RNA positive.
  • ② Active HIV infection is defined as: positive HIV antibody.
  • ③ Active hepatitis B is defined as: HBV titer ≥ 2000 IU/mL (except for subjects who have received anti-HBV treatment for at least 14 days before the first dose and agree to continue antiviral therapy during the study period).
  • Severe allergy history, or history of atopic diseases, or an allergic constitution, if any of these are met.
  • History of severe or multiple hypersensitivity to drugs or pharmaceutical preparations.
  • History of severe local or systemic reaction to vaccines, defined as:
  • Local reaction: extensive, indurated redness and swelling involving most of the arm, unresolved within 72 hours.
  • Systemic reaction: persistent fever ≥ 39.5°C within 48 hours. bronchospasm. laryngeal edema. syncope. convulsions or encephalopathy within 72 hours.
  • Severe dysfunction of other organs or heart and lung diseases.
  • History of definite neurological or psychiatric disorders, including epilepsy or dementia.
  • History of drug abuse or alcoholism.
  • Pregnant or breastfeeding women, or women of childbearing age with a positive blood pregnancy test, or patients and their partners of childbearing potential unwilling to use effective contraception during the clinical study and for 6 months after the end of treatment.
  • Patients deemed unsuitable to participate in this clinical trial by the investigator.
  • Patients with any of the following were excluded from the study:
  • Cervical carcinoma in situ that can be cured by local treatment or non-HPV related cervical cancer.
  • Has not recovered or be reasonably explained from all toxicities related to prior treatments such as surgery, radiotherapy, chemotherapy, immunotherapy, etc.
  • Participated in another clinical trial or is in the observation period of another clinical trial within 30 days prior to screening.
  • Received any non-live vaccine injection within 2 weeks prior to the first dose.
  • Received any live vaccine injection within 4 weeks prior to the first dose.
  • 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.
  • 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).
  • 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.
  • 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.
  • Central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastasis).
  • Clinically significant or recurrent pleural, peritoneal, or pericardial effusion requiring frequent drainage.
  • Uncontrolled severe infections (>Grade 2 NCI-CTCAE adverse events, version 5.0).
  • History of HIV infection or syphilis carrier.
  • Active infection (e.g., acute bacterial infection, tuberculosis, active syphilis, active phase of herpes zoster virus infection, active hepatitis B or C, etc.).
  • ① Active hepatitis C is defined as: positive hepatitis C antibody and HCV-RNA positive.
  • ② Active HIV infection is defined as: positive HIV antibody.
  • ③ Active hepatitis B is defined as: HBV titer ≥ 2000 IU/mL (except for subjects who have received anti-HBV treatment for at least 14 days before the first dose and agree to continue antiviral therapy during the study period).
  • Severe allergy history, or history of atopic diseases, or an allergic constitution, if any of these are met.
  • History of severe or multiple hypersensitivity to drugs or pharmaceutical preparations.
  • History of severe local or systemic reaction to vaccines, defined as:
  • Local reaction: extensive, indurated redness and swelling involving most of the arm, unresolved within 72 hours.
  • Systemic reaction: fever ≥ 39.5°C within 48 hours. bronchospasm. laryngeal edema. syncope. convulsions or encephalopathy within 72 hours.
  • Severe dysfunction of other organs or heart and lung diseases.
  • History of definite neurological or psychiatric disorders, including epilepsy or dementia.
  • History of drug abuse or alcoholism.
  • Pregnant or breastfeeding women, or women of childbearing age with a positive blood pregnancy test, or patients and their partners of childbearing potential unwilling to use effective contraception during the clinical study and for 6 months after the end of treatment.
  • Patients deemed unsuitable to participate in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country.

Guodong Sun, Master contact

(+86)0530-5613206

sunguodong0723@163.com

China1 site, 1 recruiting

  • Heze Municipal Hospita

    Heze, Shandong

    Guodong Sun, Master, (+86)0530-5613206, sunguodong0723@163.com

    Guodong Sun, Master

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy Study of NWRD09 in HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients

This is a single-arm, open label, two cohorts, multi-center clinical study to evaluate the safety and efficacy of HPV-16 targeted mRNA vaccine (NWRD09) in HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).

Read the detailed description

This study is divided into three dose groups in two cohorts. 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.

For cohort A, the subjects shall continue to receive safety follow-up until 14 days after the last administration. Colposcopy and biopsy were performed at week 24.

For cohort B, the subjects shall continue to receive safety follow-up until 14 days after the last administration. Imaging evaluation was performed every 6 weeks.

Being tested
NWRD09 administered by intramuscular injection
Keywords
HPV16, Intraepithelial Neoplasia, Cervical Cancer, mRNA vaccine
Medical subject headings
Carcinoma in Situ, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NWRD09 administered by intramuscular injectionBiological

    NWRD09 administered by intramuscular injection according to the study protocol.

Study groups in NCT07092007
Study groupRoleWhat they receive
Cohort A( HPV-16 related Cervical, vaginal, and vulvar intraepithelial neoplasia patients )ExperimentalPatients 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 administered by intramuscular injection
Cohort B(HPV-16 related cervical cancer patients)ExperimentalPatients 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 administered by intramuscular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety（Cohort A and B）

    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: From first administration of NWRD09 to 14 days after the last administration

  2. Dose-limiting toxicity (DLT) （Cohort A and B）

    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 21 days of the first dosing will be classified as DLT during dosing climb.

    Measured: 14 days after the first administration

Secondary outcomes (6)

  1. Immunogenicity （Cohort A and B）

    Immunologic reactogenicity by measuring HPV16 E6/E7 specific T cell response (IFN-γ ELISPOT) in blood samples.

    Measured: To week 24.

  2. Histopathology outcome and HPV Viral clearance （Cohort A）

    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: To week 24.

  3. Objective Response Rate (ORR) （Cohort B）

    bjective Response Rate (ORR), defined as the proportion of patients who have either confirmed CR or confirmed PR as best overall response per RECIST 1.1.

    Measured: To week 24.

  4. Progression-free survival (PFS) （Cohort B）

    Progression-free survival (PFS), defined as the time from the NWRD09 treatment start date to the date of the first documented progression or death from any cause, whichever occurs first.

    Measured: To week 24.

  5. Duration of response (DOR) （Cohort B）

    Duration of response (DOR), defined as time from the date of first documented response of CR or PR to the date of the first documented progression or death due to any cause.

    Measured: To week 24.

  6. Disease control rate (DCR) （Cohort B）

    Disease control rate (DCR), defined as is the percentage of evaluable cases with response (PR + CR) and stable disease (SD) after treatment, DCR = CR + PR + SD.

    Measured: To week 24.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2025
  2. Study start5 Jun 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
3+3 dose climb
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092007
Sponsor's protocol ID
NEWISH-HPV-M001
Status last verified
Jul 2024
First submitted
21 Jul 2025
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NWRD09 administered by intramuscular injection in people with Intraepithelial Neoplasia and Cervical Cancer, run by Newish Technology (Beijing) 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 20 inclusion and 59 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: status not confirmed, as of the sponsor's last update on 29 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guodong Sun, Master ((+86)0530-5613206, sunguodong0723@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety（Cohort A and B） (time frame: From first administration of NWRD09 to 14 days after the last administration). 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?

On the ClinicalTrials.gov record for NCT07092007.

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 29 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in