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New treatment option for Intraepithelial Neoplasia
Official title NWRD09 for HPV-16 Positive and HPV-16 Related Intraepithelial Neoplasia and Cervical Cancer Patients.
ClinicalTrials.gov ID: NCT06741150
What this study is testing
What is NWRD09 administered by intramuscular injection?
NWRD09 administered by intramuscular injection is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for intraepithelial neoplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 positive and HPV-16 related cervical, vaginal, and vulvar intraepithelial neoplasia (LSIL and HSIL) patients (cohort A) and HPV-16 related cervical cancer patients (cohort B).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join if
- for cohort A: Patients had to meet all of the following
- Women aged between 18 and 60 years.
- HPV16 is positive during the screening period, and other subtypes of HPV co-infection can be included. In the case of HSIL, it is necessary to meet...
- Eligible people of childbearing potential must agree to use a reliable method of contraception (hormonal or barrier method or abstinence, etc.) with...
- Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all...
You likely can't join if
- Exclusion criteria for cohort A: 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.
See the full eligibility criteria
Who can join
- for cohort A: Patients had to meet all of the following
- Women aged between 18 and 60 years.
- HPV16 is positive during the screening period, and other subtypes of HPV co-infection can be included. In the case of HSIL, it is necessary to meet the requirements of satisfactory colposcopy at screening, which is...
- Eligible people 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...
- 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. for...
- 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 two lines of...
- 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...
- 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...
- 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 people without liver metastases, and ≤ 5.0 ULN for people with liver...
- 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 people 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...
- 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.
What rules you out
- Exclusion criteria for cohort A: 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.
- 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...
- 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...
- 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...
- 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...
- Patients deemed unsuitable to participate in this clinical trial by the investigator. Exclusion criteria for cohort B: 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...
- 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...
- 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...
- 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...
- Patients deemed unsuitable to participate in this clinical trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuxi, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuxi, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.