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Experimental vaccine aims to clear precancerous cervical lesions without surgery

NCT ID NCT07702656

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests an experimental vaccine called SYS6026 in people with high-grade cervical lesions caused by HPV type 16 or 18. The goal is to see if the vaccine can help the body clear the virus and reverse the lesions, potentially avoiding the need for surgery. Participants are randomly assigned to receive different doses of SYS6026 or a placebo, and their response is monitored over 36 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental therapeutic vaccine called SYS6026
What this could lead to
If successful, this could offer a non-surgical treatment option for high-grade cervical lesions caused by HPV16 or 18.
What could go wrong
This is an early Phase II trial with a small number of participants, so results may not confirm effectiveness or safety. The treatment may not lead to lesion regression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 175 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * Major organ function was normal within one week prior to the first vaccination: 1. Blood count: Hb≥100 g/L; PLT≥100×109/L; Neutrophil count≥ 1.5×109/L; 2. Liver: TB≤ 1.5× ULN; ALT and AST ≤ 2.5× ULN; Plasma albumin ≥30 g/L; 3. Kidney: Scr ≤ 1.5× ULN, or creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula); 4. 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: 1. On the day of the first vaccination, the axillary temperature ≤ 37.0°C; 2. 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 Exclusion Criteria: * 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; * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CSPC Megalith Biopharmaceutical Co., Ltd.

    Shijiazhuang, Hebei, 050035, China