Persistent HPV16 InfectionPhase 1/2NCT07536282
Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection
A Phase 1/2 study testing NWRD09 in people with Persistent HPV16 Infection, run by Newish Biotech (Wuxi) Co., Ltd. at 1 site in United States.
Trial summary
This is a two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Persistent HPV16 Infection
- What is being tested?
- NWRD09
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Nov 2027
- Phase
- Phase 1/2
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants who have fully understood the study, able and willing to comply with all study procedures, and voluntarily sign written ICF;
- Female participants aged 18-60 years (inclusive) at the time of signing the ICF;
- Persistent HPV16 infection, defined as virologically confirmed HPV16 positivity persisting for ≥ 6 months before screening (e.g., participants must provide investigator-approved evidence of HPV16 infection ≥ 6 months prior to screening and be HPV16 positive at the time of screening);
- Participants must have a confirmed cytological results of atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H) or high-grade squamous intraepithelial lesion (HSIL) at the time of screening (histopathological confirmed cervical/vaginal/vulvar LSIL are acceptable but not required);
- Satisfactory colposcopy at screening;
- Normal major organ functions at screening;
- Women of child-bearing potential must have a negative serum pregnancy test result at screening. All WOCBP participants agree to voluntarily use effective contraception, from signing the ICF to the end of the study. In addition, female participants must agree not to donate eggs during this period.
Who cannot join
- Histopathological confirmed high-grade cervical, vulvar, vaginal or anal intraepithelial lesions (including endocervical adenocarcinoma-in-situ [AIS]) or invasive cancer, OR cervical cytology results showing squamous cell carcinoma (SCC), atypical glandular cells (AGC), or AIS at screening;
- Negative for HPV16 as confirmed by real-time quantitative polymerase chain reaction (RT-qPCR) at screening;
- Comorbid infectious diseases, such as acute pelvic inflammatory disease, urinary tract infection, or other active infections requiring systemic treatment prior to the first injection;
- Participants with unresolved vaginal/cervical conditions prior to the first injection that could affect clinical response (e.g., common sexually transmitted infections such as gonorrhoea, genital herpes, etc.);
- Positive serological test results at screening for human immunodeficiency virus (HIV), treponema pallidum antibody, or hepatitis B virus surface antigen (HBsAg) positive; or hepatitis C virus antibody (HCV-Ab) positive and hepatitis C virus (HCV) ribonucleic acid (RNA) quantitative > the lower limit of the positive detection value of the study site;
- Significant abnormalities at the screening ECG, including QTc interval > 470 msec (average of triplicate measurements corrected for heart rate using Fridericia's formula), or history/presence of clinical symptoms of cardiac diseases that is not well controlled, such as New York Heart Association (NYHA) Class 2 or higher heart failure, unstable angina, myocardial infarction within the past 6 months, and clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
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- Systemic corticosteroid use (e.g., > 10 mg/day prednisone for > 1 week) within 30 days before screening, excluding hormone replacement therapy and local/topical use (e.g., ocular, intratracheal);
- Immunosuppressant use (> 1 week) within 30 days or 5 drug half-lives (whichever is longer) before screening (including but not limited to cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, or antilymphocyte globulin);
- Current or planned use of disease-modifying antirheumatic drugs (DMARDs, e.g., azathioprine, cyclophosphamide, cyclosporine, methotrexate) or biologic DMARDs (e.g., infliximab, adalimumab, etanercept) during the study;
- Received any vaccine (other than HPV prophylactic vaccines) within 8 weeks before screening or plan to receive any vaccine during the study;
- History of therapeutic HPV vaccination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Columbia University Medical Center
New York, New York, 10032
June Y. Hou, MD, 212-305-3410, irboffice@columbia.edu
June Y. Hou, MD
About this study
Official title: A Phase I/IIa, Randomized, Double Blind, Placebo Controlled, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of NWRD09 Injection in Female Participants With Persistent HPV16 Infection
This is a two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09.
- Conditions
- Persistent HPV16 Infection
- Being tested
- NWRD09, Placebo
- Keywords
- persistent HPV16 infection, therapeutic mRNA vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NWRD09Biological
Participants will receive 4 injections of NWRD09 via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1)
PlaceboBiological
Participants will receive 4 injections of Placebo via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1)
| Study group | Role | What they receive |
|---|---|---|
| NWRD09 | Experimental | Predefined dose groups of NWRD09 Receives: Biological: NWRD09 |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Week 28
Secondary outcomes (5)
Proportion of participants with clearance of HPV16
Measured: Weeks 16 and 28
Proportion of participants with cervical cytology normal/ASC-US/LSIL
Measured: Week 16 and 28
For participants with histopathological LSIL at baseline, proportion of participants with histopathological regression to NSIL
Measured: Week 28
T cell responses to the separate or combined protein peptide pools of HPV16 E1, E2, E6 and E7 proteins
Measured: Weeks 6, 16 and 28
Serum HPV16 E6/E7-specific IgG antibodies will be determined by ELISA
Measured: Weeks 6, 16 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent HPV16 InfectionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 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
- NCT07536282
- Sponsor's protocol ID
- NWRD09-103
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Randomized, Double Blind, Placebo Controlled, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of NWRD09 Injection in Female Participants With Persistent HPV16 Infection
- ClinicalTrials.gov ID
- NCT07536282
- Acronym / sponsor ID
- NWRD09-103
- Conditions
- Persistent HPV16 Infection
- Keywords
- persistent HPV16 infection, therapeutic mRNA vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Newish Biotech (Wuxi) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Apr 2026 (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 two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NWRD09 | Experimental | Biological: NWRD09Predefined dose groups of NWRD09 |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants who have fully understood the study, able and willing to comply with all study procedures, and voluntarily sign written ICF;
- Female participants aged 18-60 years (inclusive) at the time of signing the ICF;
- Persistent HPV16 infection, defined as virologically confirmed HPV16 positivity persisting for ≥ 6 months before screening (e.g., participants must provide investigator-approved evidence of HPV16 infection ≥ 6 months prior to screening and be HPV16 positive at the time of screening);
- Participants must have a confirmed cytological results of atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H) or high-grade squamous intraepithelial lesion (HSIL) at the time of screening (histopathological confirmed cervical/vaginal/vulvar LSIL are acceptable but not required);
- Satisfactory colposcopy at screening;
Key exclusion criteria (11 listed)
- Histopathological confirmed high-grade cervical, vulvar, vaginal or anal intraepithelial lesions (including endocervical adenocarcinoma-in-situ [AIS]) or invasive cancer, OR cervical cytology results showing squamous cell carcinoma (SCC), atypical glandular cells (AGC), or AIS at screening;
- Negative for HPV16 as confirmed by real-time quantitative polymerase chain reaction (RT-qPCR) at screening;
- Comorbid infectious diseases, such as acute pelvic inflammatory disease, urinary tract infection, or other active infections requiring systemic treatment prior to the first injection;
- Participants with unresolved vaginal/cervical conditions prior to the first injection that could affect clinical response (e.g., common sexually transmitted infections such as gonorrhoea, genital herpes, etc.);
- Positive serological test results at screening for human immunodeficiency virus (HIV), treponema pallidum antibody, or hepatitis B virus surface antigen (HBsAg) positive; or hepatitis C virus antibody (HCV-Ab) positive and hepatitis C virus (HCV) ribonucleic acid (RNA) quantitative > the lower limit of the positive detection value of the study site;
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 |
|---|---|---|
| NWRD09Participants will receive 4 injections of NWRD09 via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1) | Biological | NWRD09 |
| PlaceboParticipants will receive 4 injections of Placebo via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1) | Biological | Placebo |
Primary outcome
Incidence and severity of local and systemic adverse events (AEs).
Time frame: Up to Week 28
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.
5 secondary outcomes
Proportion of participants with clearance of HPV16
Time frame: Weeks 16 and 28
Proportion of participants with cervical cytology normal/ASC-US/LSIL
Time frame: Week 16 and 28
For participants with histopathological LSIL at baseline, proportion of participants with histopathological regression to NSIL
Time frame: Week 28
T cell responses to the separate or combined protein peptide pools of HPV16 E1, E2, E6 and E7 proteins
Time frame: Weeks 6, 16 and 28
Serum HPV16 E6/E7-specific IgG antibodies will be determined by ELISA
Time frame: Weeks 6, 16 and 28
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 17 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Persistent HPV16 Infection
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Phase I/II Trial of Electroporation-Delivered pBI-4 Vaccine (TriGrid™ PVX4) for Treatment of Women With HPV16-Positive CIN1 or Persistent Infection
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RecruitingPhase 1
A Study of NWRD09 in Participants With Persistent HPV16 Infection in the Anal Region
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NWRD09 for Persistent Cervical HPV16 Infection
Persistent Cervical HPV16 Infection
Active, not recruitingObservational study
Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls
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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 1/2 study testing NWRD09 in people with Persistent HPV16 Infection, run by Newish Biotech (Wuxi) Co., Ltd. at 1 site in United States.
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 11 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: opening soon, as of the sponsor's last update on 17 Apr 2026. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 June Y. Hou, MD (212-305-3410, jh3558@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of local and systemic adverse events (AEs). (time frame: Up to Week 28). 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 17 Apr 2026.