NCT07668960尚未招募1 期
A Phase I/ IIa, Open-Label, Single-Arm, Dose-Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesions.
Shanghai Mianyi Biopharmaceutical Co., Ltd.4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 4
研究概览
简要总结
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 .
排除标准
- •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).
- •Any other conditions judged by the Investigator that may affect a participant's safety or compliance .
研究者
研究点 (4)
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