Evaluation of the Safety, Tolerability, Immunogenicity and Preliminary Efficacy of BBM-C101 Injection in Patients With Cervical High-Grade Squamous Intraepithelial Lesion(HSIL)

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.

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 .

Study Overview

• Status: Not yet recruiting
• Conditions: High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection
• Intervention / Treatment: Drug: BBM-C101

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xia Wu, PhD; Phone Number: 15721557980; Email: wu-xia@beliefbiomed.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Peking University People's Hospital
      • Contact: Jianliu Wang, MD; Phone Number: 18901086568; Email: wangjianliu1203@163.com
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400010
      • The Second Affiliated Hospital of Chongqing Medical University
      • Contact: Xiaojing Dong, MM; Phone Number: 13648437247; Email: dongxiaojing@cqmu.edu.cn
  • Henan
    • Zhangzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
      • Contact: Yue Wang, MD; Phone Number: 13523583939; Email: wangyue0601@163.com
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University
      • Contact: Youzhong Zhang, MD; Phone Number: 13711222638; Email: zhangyouzhong@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically confirmed HPV16 and/or HPV18 associated HSIL.
2. 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.
3. 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 .
4. Willing to voluntarily participate in the study and provide written informed consent .

5. 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 .

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Exclusion Criteria:

1. 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 .
2. Participants who have received any treatment for HPV positivity or cervical HSIL prior to study drug.
3. History of previous therapeutic HPV vaccination ( except for the licensed prophylactic HPV vaccines ).
4. Participants who have used any local or systemic immunosuppressive agents prior to the first administration of BBM-C101 injection .
5. Received any licensed vaccines within 2 weeks prior to study drug administration .
6. Participants with acute cervical inflammation or acute exacerbation of chronic cervical disease .
7. Positive results were obtained in the tests for hepatitis C virus antibody, human immunodeficiency virus (HIV).
8. Having participated in other clinical trials before signing the informed consent form, including studies involving investigational drugs or devices.
9. Participants who are unable or unwilling to undergo colposcopy, or have contraindications to colposcopy.
10. Participants who have received any gene therapy treatment prior to screening, or plans to receive any other gene therapy treatment during the study period.

11. 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:

    1. White blood cell count < 3.0 × 10⁹/L;
    2. Hemoglobin < 90 g/L;
    3. Platelet < 100 × 10⁹/L;
    4. Aspartate aminotransferase or alanine aminotransferase > 2 × upper limit of normal (ULN);
    5. Total bilirubin > 1.5 × ULN;
    6. Creatinine > 1.5 × ULN.
12. 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.
13. Participants with active infections requiring systemic anti-infective therapy.
14. 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).
15. Participants with a known history of malignant tumors in any organ/system (regardless of evidence of local recurrence or metastasis) .
16. Participants with a history of severe allergic diseases ( e.g., allergy-related shock, dyspnea, angioedema) ).
17. Active drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements .
18. Major surgery or significant trauma within 4 weeks prior to the first dose .
19. Pregnant or breastfeeding (lactating).

20. Any other conditions judged by the Investigator that may affect a participant's safety or compliance .

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm of BBM-C101	Drug: BBM-C101; hypodermic injection , once a week, for a total of 4 administrations. Low dose group， Middle dose group； High dose group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase I: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); Incidence of dose limiting toxicity (DLT) events	within 5 weeks
Phase I: Determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase II Dose (RP2D)	within 5 weeks
Phase IIa： The percentage of cervical lesions that have regressed to CIN1 or normal as confirmed by virology and histopathology	within 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Phase I: The percentage of cervical lesions that have regressed to CIN1 or normal, as confirmed by virology and histopathology studies	within 52 weeks
Phase I&Phase IIa: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	within 52 weeks
Phase I&Phase IIa: Percentage of HPV and E6E7 mRNA elimination	within 52 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mianyi Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 17, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 21, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: gene therapy; Adeno Virus
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Papillomavirus Infections
• Other Study ID Numbers: BBM040-CLN1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No