Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)
Starting soon · Phase 1/Phase 2
Conditions studied: High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection
In brief
The goal of this study is to learn about the safety, tolerability, immunogenicity and preliminary efficacy of BBM-C101 injection in patients with High-Grade Squamous Intraepithelial Lesion of the cervix. This study include two phases: Phase I and Phase IIa .
Key facts
- Study ID
- NCT07668960
- Run by
- Shanghai Mianyi Biopharmaceutical Co., Ltd.
- People needed
- 60
- Starts
- 2026-06-17
- Expected to finish
- 2029-12-30
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed HPV16 and/or HPV18 associated HSIL.
- Colposcopy findings at screening at each study center must meet all of the following conditions: The colposcopy examination should be satisfactory and The ECC result must be negative.
- Women of childbearing potential must agree to use highly effective contraception together with their partner throughout the study and for at least 1 year after the first dose ; f and a serum pregnancy test within 7 days prior to enrollment must be negative .
- Willing to voluntarily participate in the study and provide written informed consent .
- In the opinion of the Investigator, the participant is expected to demonstrate good compliance and be able to complete all scheduled visits and follow-up assessments in accordance with the study protocol .
You may not qualify if…
- During screening, cytological or histopathological shows any of the following results: adenocarcinoma in situ (AIS), atypical glandular cells-favor neoplasia (AGC-FN), or invasive carcinoma .
- Participants who have received any treatment for HPV positivity or cervical HSIL prior to study drug.
- History of previous therapeutic HPV vaccination ( except for the licensed prophylactic HPV vaccines ).
- Participants who have used any local or systemic immunosuppressive agents prior to the first administration of BBM-C101 injection .
- Received any licensed vaccines within 2 weeks prior to study drug administration .
- Participants with acute cervical inflammation or acute exacerbation of chronic cervical disease .
- Positive results were obtained in the tests for hepatitis C virus antibody, human immunodeficiency virus (HIV).
- Having participated in other clinical trials before signing the informed consent form, including studies involving investigational drugs or devices.
- Participants who are unable or unwilling to undergo colposcopy, or have contraindications to colposcopy.
- Participants who have received any gene therapy treatment prior to screening, or plans to receive any other gene therapy treatment during the study period.
- Participants with clinically significant abnormal values in laboratory tests during screening, as determined by the Investigator to increase risk to the participant's participation in the clinical trial . This includes, but is not limited to, any of the following:
- White blood cell count < 3.0 × 10⁹/L;
- Hemoglobin < 90 g/L;
- Platelet < 100 × 10⁹/L;
- Aspartate aminotransferase or alanine aminotransferase > 2 × upper limit of normal (ULN);
- Total bilirubin > 1.5 × ULN;
- Creatinine > 1.5 × ULN.
- Participants with a history or diagnosis of autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis , uveitis, autoimmune hepatitis, systemic sclerosis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barré syndrome), etc.
- Participants with active infections requiring systemic anti-infective therapy.
- Participants with unstable cardiovascular or cerebrovascular diseases, defined as clinical cardiovascular event (such as unstable angina, myocardial infarction, stroke, etc.) occurring within 3 months prior to screening; participants with severe uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Participants with a known history of malignant tumors in any organ/system (regardless of evidence of local recurrence or metastasis) .
- Participants with a history of severe allergic diseases ( e.g., allergy-related shock, dyspnea, angioedema) ).
- Active drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements .
- Major surgery or significant trauma within 4 weeks prior to the first dose .
- Pregnant or breastfeeding (lactating).
Where it is running
- Peking University People's Hospital — Beijing, Beijing Municipality, China
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
- Henan Provincial People's Hospital — Zhangzhou, Henan, China
- Qilu Hospital of Shandong University — Jinan, Shandong, China
Full record on ClinicalTrials.gov
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