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

NCT07668960 | Not Yet Recruiting Phase 1

• 1 other identifier: BBM040-CLN1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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 .

Conditions

High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection

Keywords

gene therapy; Adeno Virus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (1)

Arm of BBM-C101

EXPERIMENTAL

Drug: BBM-C101

Interventions

BBM-C101 DRUG

hypodermic injection , once a week, for a total of 4 administrations. Low dose group， Middle dose group； High dose group

Arm of BBM-C101

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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);

Sponsors & Collaborators

• Shanghai Mianyi Biopharmaceutical Co., Ltd.: lead

Study Sites (4)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Henan Provincial People's Hospital

Zhangzhou, Henan, 450003, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xia Wu, PhD

CONTACT

15721557980; wu-xia@beliefbiomed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)