Investigator-Initiated Study of BBM-C101 Injection in Subjects With HPV16/18 Infection (NCT07714577) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Investigator-Initiated Study of BBM-C101 Injection in Subjects With HPV16/18 Infection
200 participantsStarted 2026-07-30
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
.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;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Tolerability of BBM040 Injection Within 52 Weeks After Administration
. 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.
. 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.