High-grade Cervical Intraepithelial LesionsPhase 2NCT07702656
A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions
A Phase 2 study testing SYS6026 in people with High-grade Cervical Intraepithelial Lesions, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High-grade Cervical Intraepithelial Lesions
- What is being tested?
- SYS6026
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 30 Dec 2028
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age must be 18 years old or above;
- During the screening period, the research center confirmed participants with HPV type 16 and/or type 18 cervical infection;
- During screening, the research center confirmed histological evidence of cervical HSIL (CIN grade 2~CIN3) (lesions may be obtained within 3 months prior to the first study treatment);
- Colposcopy results at each research center during the screening period must meet the following conditions: 1) Fully visible squamous-columnar epithelial junction (type I or type II transformation zone), with fully visible upper white acetic acid epithelial or suspected CIN lesions; 2) Cervical lesions can be touched and sampled by biopsy instruments, and the cervical lesions are sufficiently large to ensure visible lesions remain for observation during the study period;
- Consent was given to undergo lesion biopsy during the screening period and to perform surgical resection or biopsy at 36 weeks after the first vaccination;
- During the screening period, sufficient lesion tissue biopsy samples and cervical swab samples can be obtained for CIN and HPV testing in the central laboratory;
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- Major organ function was normal within one week prior to the first vaccination:
- Blood count: Hb≥100 g/L; PLT≥100×109/L； Neutrophil count≥ 1.5×109/L;
- Liver: TB≤ 1.5× ULN; ALT and AST ≤ 2.5× ULN; Plasma albumin ≥30 g/L;
- Kidney: Scr ≤ 1.5× ULN, or creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula);
- Coagulation function: PT, APTT, and INR ≤1.5× ULN;
- The investigator determined that the ECG during the screening period was normal or without clinically significant results; 9) Normal vital sign test results:
- On the day of the first vaccination, the axillary temperature ≤ 37.0°C;
- Systolic pressure < 140 mmHg and diastolic pressure < 90 mmHg;
- Eligible participants with fertility must agree to use reliable contraceptive methods (hormonal contraceptives, barrier therapy, or abstinence) with their partner during the trial and for at least one year after the last dose; Female participants of childbearing age must have a negative blood pregnancy test within 7 days prior to enrollment;
- Fully understand this clinical trial and voluntarily sign a written informed consent form
Who cannot join
- Screening combined with other high-risk HPV subtypes (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68);
- Cases with VIN/VAIN/AIN or AIS or other lesions should be excluded.
- During screening, cytological or histopathological examination yields any of the following: AIS, AGC-FN, invasive cancer, etc.;
- HSIL treatment within 4 weeks prior to the first vaccination;
- Previous receipt of therapeutic HPV vaccines (approved preventive HPV vaccines are permitted);
- Received any live vaccine injection within 4 weeks prior to the first vaccination or received any live vaccine injection within 2 weeks;
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- Previous or current history of other malignant tumors (except for the following tumors: ductal carcinoma in situ that has been fully treated and completely cured, basal cell carcinoma of the skin, superficial bladder tumors, or any malignant tumor cured more than 2 years prior to study entry);
- Having active autoimmune disease or a history of autoimmune disease;
- Other immune dysfunction conditions, such as receiving immunosuppressive or immunosuppressive therapy within 3 months (continuous oral or infusion for more than 14 days); or those who have received whole blood, plasma, or immunoglobulin therapy within the past month; Or those with known immunological impairment or impairment diagnosed by hospitals, or any condition leading to functional splenectomy or splenectomy;
- A history of severe allergy to any vaccine or known components of SYS6026 injections;
- Participated in other clinical trials within 4 weeks prior to the first use of the investigational vaccine;
- Surgical procedure or significant trauma within 4 weeks prior to the first use of the investigational vaccine;
- Fever (axillary temperature ≥ 38.0°C) within 3 days before first use of the trial vaccine, acute illness or acute exacerbation of chronic disease within the first 5 days, or fever-reducer, analgesic, or anti-allergy medication taken within 3 days before the first trial vaccine dose; Hepatitis C virus infection;
- Active hepatitis B (hepatitis B virus titer> 1000 copies/mL or 200 IU/mL), allowing prophylactic antiviral therapy other than interferon;
- History of immunodeficiency, or positive HIV antibody test;
- Accompanied by systemic active bacterial, fungal, or viral infections (defined as requiring intravenous antibacterial, antifungal, or antiviral drug treatment);
- Long-term (≥7-day) systemic use of glucocorticoids (prednisone ≥20 mg/day or equivalent dose) or other immunosuppressive treatments (short-term glucocorticoids are allowed for preventive treatment; Topical use of glucocorticoids is permitted, such as ocular, intra-articulary, intranasal, and inhaled types. Current or planned use of antirheumatic or immunomodulatory drugs, such as azathioprine, cyclophosphamide, cyclosporine, methotrexate, and TNFα inhibitors (such as infliximab, adalimumab, or etanercept), etc.;
- History of solid organ transplantation or bone marrow transplantation;
- Pregnant or breastfeeding women;
- Other circumstances that may interfere with participant participation in study procedures or may not align with the maximum benefit or impact on study outcomes: such as a history of mental illness, drug use, or drug abuse, any other clinically significant diseases or conditions, such as medically unstable diseases (e.g., chronic kidney failure; Angina, myocardial ischemia or infarction, grade 3 or higher congestive heart failure, cardiomyopathy, or clinically significant arrhythmias), etc.
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
CSPC Megalith Biopharmaceutical Co., Ltd.
Shijiazhuang, Hebei, 050035
Jianliu Wang, +86 010-88326666, wangjianliu1203@163.com
About this study
This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).
Read the detailed description
Approximately 175 participants were planned to be enrolled, initially randomized at a 2:2:2:1 ratio to SYS6026 three dose groups and placebo groups.
- Being tested
- SYS6026, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6026Biological
Administration continued until D168
PlaceboBiological
Administration continued until D168
| Study group | Role | What they receive |
|---|---|---|
| SYS6026, dose1,subcutaneous injection, three primary immunizations and one booster | Experimental | Not described Receives: Biological: SYS6026 |
| SYS6026, dose2,subcutaneous injection, three primary immunizations and one booster | Experimental | Not described Receives: Biological: SYS6026 |
| SYS6026, dose3,subcutaneous injection, three primary immunizations and one booster | Experimental | Not described Receives: Biological: SYS6026 |
| Placebo, subcutaneous injection, three primary immunizations and one booster | Experimental | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants whose pathology had resolved/remission to CIN1 and HPV16/18 negative at 36 weeks post-vaccination (independent pathology review)
Measured: 24 months
Secondary outcomes (5)
Proportion of participants whose pathology had regression/downgraded at 36 weeks after first vaccination (independent pathology review)
Measured: 24 months
Proportion of participants with pathological normal conditions at 36 weeks post-vaccination (independent pathology review)
Measured: 24 months
The incidence and severity of AE and SAE during the study period
Measured: 24 months
Serum titers of anti-HPV16 E6/E7 and anti-HPV18 E6/E7 binding antibodies were assessed
Measured: 24 months
Serum cytokine levels are assessed, including IL-1β, IL-6, TNFα, IFNγ, etc.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Cervical Intraepithelial LesionsStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- High-grade cervical intraepithelial lesions associated with human papillomavirus type 16/18
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702656
- Sponsor's protocol ID
- SYS6026-004
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions
- ClinicalTrials.gov ID
- NCT07702656
- Acronym / sponsor ID
- SYS6026-004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Jul 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 trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).
Detailed description
Approximately 175 participants were planned to be enrolled, initially randomized at a 2:2:2:1 ratio to SYS6026 three dose groups and placebo groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- High-grade cervical intraepithelial lesions associated with human papillomavirus type 16/18
| Arm | Type | Receives |
|---|---|---|
| SYS6026, dose1,subcutaneous injection, three primary immunizations and one booster | Experimental | Biological: SYS6026 |
| SYS6026, dose2,subcutaneous injection, three primary immunizations and one booster | Experimental | Biological: SYS6026 |
| SYS6026, dose3,subcutaneous injection, three primary immunizations and one booster | Experimental | Biological: SYS6026 |
| Placebo, subcutaneous injection, three primary immunizations and one booster | Experimental | Biological: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age must be 18 years old or above;
- During the screening period, the research center confirmed participants with HPV type 16 and/or type 18 cervical infection;
- During screening, the research center confirmed histological evidence of cervical HSIL (CIN grade 2~CIN3) (lesions may be obtained within 3 months prior to the first study treatment);
- Colposcopy results at each research center during the screening period must meet the following conditions: 1) Fully visible squamous-columnar epithelial junction (type I or type II transformation zone), with fully visible upper white acetic acid epithelial or suspected CIN lesions; 2) Cervical lesions can be touched and sampled by biopsy instruments, and the cervical lesions are sufficiently large to ensure visible lesions remain for observation during the study period;
- Consent was given to undergo lesion biopsy during the screening period and to perform surgical resection or biopsy at 36 weeks after the first vaccination;
Key exclusion criteria (20 listed)
- Screening combined with other high-risk HPV subtypes (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68);
- Cases with VIN/VAIN/AIN or AIS or other lesions should be excluded.
- During screening, cytological or histopathological examination yields any of the following: AIS, AGC-FN, invasive cancer, etc.;
- HSIL treatment within 4 weeks prior to the first vaccination;
- Previous receipt of therapeutic HPV vaccines (approved preventive HPV vaccines are permitted);
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 |
|---|---|---|
| SYS6026Administration continued until D168 | Biological | SYS6026, dose1,subcutaneous injection, three primary immunizations and one booster, SYS6026, dose2,subcutaneous injection, three primary immunizations and one booster, SYS6026, dose3,subcutaneous injection, three primary immunizations and one booster |
| PlaceboAdministration continued until D168 | Biological | Placebo, subcutaneous injection, three primary immunizations and one booster |
Primary outcome
Proportion of participants whose pathology had resolved/remission to CIN1 and HPV16/18 negative at 36 weeks post-vaccination (independent pathology review)
Time frame: 24 months
5 secondary outcomes
Proportion of participants whose pathology had regression/downgraded at 36 weeks after first vaccination (independent pathology review)
Time frame: 24 months
Proportion of participants with pathological normal conditions at 36 weeks post-vaccination (independent pathology review)
Time frame: 24 months
The incidence and severity of AE and SAE during the study period
Time frame: 24 months
Serum titers of anti-HPV16 E6/E7 and anti-HPV18 E6/E7 binding antibodies were assessed
Time frame: 24 months
Serum cytokine levels are assessed, including IL-1β, IL-6, TNFα, IFNγ, etc.
Time frame: 24 months
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 14 Jul 2026.
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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 2 study testing SYS6026 in people with High-grade Cervical Intraepithelial Lesions, run by CSPC Megalith Biopharmaceutical 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 16 inclusion and 20 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 14 Jul 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 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 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 Clinical Trial Information Team Officer (+86-311 6908 5587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants whose pathology had resolved/remission to CIN1 and HPV16/18 negative at 36 weeks post-vaccination (independent pathology review) (time frame: 24 months). 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 14 Jul 2026.