Investigator-Initiated Study of BBM-C101 Injection in Subjects With HPV16/18 Infection

NCT07714577 | Not Yet Recruiting

• 1 other identifier: BBM040-IIT1004
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HPV16/18 Positive

Outcome Measures

Primary Outcomes (1)

• 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;

  52 weeks

Study Arms (1)

BBM-C101

EXPERIMENTAL

Drug: BBM-C101

Interventions

BBM-C101 DRUG

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；

BBM-C101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the Oncology Department of Tianjin First Central Hospital

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 20, 2026

Record last verified: 2026-07