HPV16/18 PositiveNCT07714577
Investigator-Initiated Study of BBM-C101 Injection in Subjects With HPV16/18 Infection
A study testing BBM-C101 in people with HPV16/18 Positive, run by Tianjin First Central Hospital.
Trial summary
This is a single-arm, single-center, open-label Investigator-Initiated Trial (IIT) designed to evaluate the safety and efficacy of BBM-C101 Injection in subjects with HPV16/18 infection and histopathologically confirmed ≤ Grade 2 CIN, VIN, VAIN or AIN via colposcopy or anoscopy, with a planned enrollment of 200… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV16/18 Positive
- What is being tested?
- BBM-C101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 1 Aug 2031
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HPV16 and/or HPV18 infection of the cervix, vulva, vagina or anus lasting for more than 1 year at screening; patients who decline surgical treatment or have failed prior pharmaceutical therapy (e.g., 5% imiquimod cream, 1% cidofovir gel);
- Histopathological diagnosis of ≤ Grade 2 CIN, VIN, VAIN or AIN via colposcopy or anoscopy at a local hospital (lesion specimens obtained within 3 weeks prior to the first study treatment); willing to provide biological samples throughout the study;
- 4.Screening electrocardiogram shows normal findings or no clinically significant abnormalities as judged by the investigator; 5.Fertile eligible participants must agree to use reliable contraceptive methods together with their partners during the trial and for at least 1 year after the last administration (hormonal contraceptives, barrier methods, or abstinence); female participants of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment;
Who cannot join
- Cytology results obtained during screening showing any of the following: adenocarcinoma in situ (AIS), atypical glandular cells favor neoplasia (AGC-FN), invasive carcinoma, etc.
- Received disease-related treatments within 4 weeks prior to the first vaccination, including pharmaceutical therapy (e.g., immunomodulators, fluorouracil ointment, recombinant human interleukin-2 injection), physical therapy (cryotherapy, laser therapy, photodynamic therapy), or surgical treatment.
- Prior administration of any therapeutic HPV vaccine (licensed prophylactic HPV vaccines are permitted).
- Received any vaccine within 4 weeks or 2 weeks prior to the first vaccination.
- Past or current diagnosis of other malignant tumors (exceptions: completely treated and cured ductal carcinoma in situ of breast, basal cell carcinoma of the skin, superficial bladder tumors, or any malignancy cured for more than 5 years with no evidence of recurrence prior to study entry).
- Active autoimmune disease or medical history of autoimmune disorders.
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- Other immunocompromised conditions, including subjects receiving immunostimulants or immunosuppressants within 3 months (oral or intravenous administration lasting more than 14 consecutive days); subjects receiving whole blood, plasma or immunoglobulin therapy within 1 month; subjects with clinically diagnosed impaired or deficient immune function; or functional asplenia or splenectomy due to any cause.
- Severe allergic history, history of allergic disorders, or allergic diathesis.
- Participation in another clinical trial within 4 weeks prior to the first study vaccine administration.
- Underwent major surgery or sustained significant trauma within 4 weeks prior to the first study vaccine administration.
- Active hepatitis B (HBV viral load >1000 copies/mL or 200 IU/mL; prophylactic antiviral therapy other than interferon is allowed); hepatitis C virus infection.
- History of immunodeficiency or positive HIV antibody test result.
- Systemic active bacterial, fungal or viral infection (defined as infection requiring intravenous antibacterial, antifungal or antiviral agents).
- Long-term (≥7 consecutive days) systemic glucocorticoid therapy (prednisone ≥20 mg/day or equivalent dose) or other immunosuppressants (short-term glucocorticoids for prophylaxis and topical glucocorticoids including ophthalmic, intra-articular, intranasal and inhaled formulations are permitted). Current or planned use of anti-rheumatic or immunomodulatory agents such as azathioprine, cyclophosphamide, cyclosporine, methotrexate and TNF-α inhibitors (infliximab, adalimumab, etanercept, etc.).
- History of solid organ transplantation or bone marrow transplantation.
- Pregnant or breastfeeding female subjects.
- Any other conditions that may interfere with study procedures, compromise the subject's maximum benefit from participation, or confound study outcomes, including history of psychiatric disorders, drug addiction or substance abuse, or any other clinically significant unstable medical conditions (e.g., chronic renal failure).
About this study
Official title: A Investigator-Initiated Exploratory Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Injection BBM-C101 in Subjects With HPV16/18 Infection
This is a single-arm, single-center, open-label Investigator-Initiated Trial (IIT) designed to evaluate the safety and efficacy of BBM-C101 Injection in subjects with HPV16/18 infection and histopathologically confirmed ≤ Grade 2 CIN, VIN, VAIN or AIN via colposcopy or anoscopy, with a planned enrollment of 200 subjects. The study consists of three phases: a 4-week screening period, a 52-week treatment/follow-up period, and a 52-week long-term follow-up period. Safety will be assessed based on vital signs, physical examinations, laboratory tests, as well as the number and severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring throughout the study.
- Conditions
- HPV16/18 Positive
- Being tested
- BBM-C101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBM-C101Drug
Subcutaneous injection at a dose of 2.5×10¹¹ viral particles (VP). Subjects who pass screening will enter a 21-day treatment period with a total of 4 administrations at 1-week intervals；
| Study group | Role | What they receive |
|---|---|---|
| BBM-C101 | Experimental | Not described Receives: Drug: BBM-C101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of BBM040 Injection Within 52 Weeks After Administration
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) during the treatment period;
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV16/18 PositiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Zhao, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714577
- Sponsor's protocol ID
- BBM040-IIT1004
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Investigator-Initiated Exploratory Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Injection BBM-C101 in Subjects With HPV16/18 Infection
- ClinicalTrials.gov ID
- NCT07714577
- Acronym / sponsor ID
- BBM040-IIT1004
- Conditions
- HPV16/18 Positive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 20 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 is a single-arm, single-center, open-label Investigator-Initiated Trial (IIT) designed to evaluate the safety and efficacy of BBM-C101 Injection in subjects with HPV16/18 infection and histopathologically confirmed ≤ Grade 2 CIN, VIN, VAIN or AIN via colposcopy or anoscopy, with a planned enrollment of 200 subjects. The study consists of three phases: a 4-week screening period, a 52-week treatment/follow-up period, and a 52-week long-term follow-up period. Safety will be assessed based on vital signs, physical examinations, laboratory tests, as well as the number and severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BBM-C101 | Experimental | Drug: BBM-C101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed HPV16 and/or HPV18 infection of the cervix, vulva, vagina or anus lasting for more than 1 year at screening; patients who decline surgical treatment or have failed prior pharmaceutical therapy (e.g., 5% imiquimod cream, 1% cidofovir gel);
- Histopathological diagnosis of ≤ Grade 2 CIN, VIN, VAIN or AIN via colposcopy or anoscopy at a local hospital (lesion specimens obtained within 3 weeks prior to the first study treatment); willing to provide biological samples throughout the study;
- 4.Screening electrocardiogram shows normal findings or no clinically significant abnormalities as judged by the investigator; 5.Fertile eligible participants must agree to use reliable contraceptive methods together with their partners during the trial and for at least 1 year after the last administration (hormonal contraceptives, barrier methods, or abstinence); female participants of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment;
Key exclusion criteria (17 listed)
- Cytology results obtained during screening showing any of the following: adenocarcinoma in situ (AIS), atypical glandular cells favor neoplasia (AGC-FN), invasive carcinoma, etc.
- Received disease-related treatments within 4 weeks prior to the first vaccination, including pharmaceutical therapy (e.g., immunomodulators, fluorouracil ointment, recombinant human interleukin-2 injection), physical therapy (cryotherapy, laser therapy, photodynamic therapy), or surgical treatment.
- Prior administration of any therapeutic HPV vaccine (licensed prophylactic HPV vaccines are permitted).
- Received any vaccine within 4 weeks or 2 weeks prior to the first vaccination.
- Past or current diagnosis of other malignant tumors (exceptions: completely treated and cured ductal carcinoma in situ of breast, basal cell carcinoma of the skin, superficial bladder tumors, or any malignancy cured for more than 5 years with no evidence of recurrence prior to study entry).
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 |
|---|---|---|
| BBM-C101Subcutaneous injection at a dose of 2.5×10¹¹ viral particles (VP). Subjects who pass screening will enter a 21-day treatment period with a total of 4 administrations at 1-week intervals； | Drug | BBM-C101 |
Primary outcome
Safety and Tolerability of BBM040 Injection Within 52 Weeks After Administration
Time frame: 52 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) during the treatment period;
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 20 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BBM-C101 in people with HPV16/18 Positive, run by Tianjin First Central Hospital.
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 3 inclusion and 17 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of BBM040 Injection Within 52 Weeks After Administration (time frame: 52 weeks). 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 20 Jul 2026.