High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 InfectionPhase 1/2NCT07668960
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 1/2 study testing BBM-C101 in people with High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection, run by Shanghai Mianyi Biopharmaceutical Co., Ltd. at 4 sites in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection
- What is being tested?
- BBM-C101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesChina
- Study dates
- 17 Jun 2026to 30 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
- -
Who cannot join
- 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 .
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- 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 .
- -
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jianliu Wang, MD, 18901086568, wangjianliu1203@163.com
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Xiaojing Dong, MM, 13648437247, dongxiaojing@cqmu.edu.cn
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Youzhong Zhang, MD, 13711222638, zhangyouzhong@vip.sina.com
Henan Provincial People's Hospital
Zhangzhou, Henan, 450003
Yue Wang, MD, 13523583939, wangyue0601@163.com
About this study
Official title: 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 .
- Being tested
- BBM-C101
- Keywords
- gene therapy, Adeno Virus
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBM-C101Drug
hypodermic injection , once a week, for a total of 4 administrations. Low dose group， Middle dose group； High dose group
| Study group | Role | What they receive |
|---|---|---|
| Arm of BBM-C101 | Experimental | Not described Receives: Drug: BBM-C101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); Incidence of dose limiting toxicity (DLT) events
Measured: within 5 weeks
Phase I: Determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase II Dose (RP2D)
Measured: within 5 weeks
Phase IIa： The percentage of cervical lesions that have regressed to CIN1 or normal as confirmed by virology and histopathology
Measured: 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
Measured: within 52 weeks
Phase I&Phase IIa: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: within 52 weeks
Phase I&Phase IIa: Percentage of HPV and E6E7 mRNA elimination
Measured: within 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start17 Jun 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mianyi Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668960
- Sponsor's protocol ID
- BBM040-CLN1001
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07668960
- Acronym / sponsor ID
- BBM040-CLN1001
- Keywords
- gene therapy, Adeno Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mianyi Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm of BBM-C101 | Experimental | Drug: BBM-C101 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (27 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBM-C101hypodermic injection , once a week, for a total of 4 administrations. Low dose group， Middle dose group； High dose group | Drug | Arm of BBM-C101 |
Primary outcome
Phase I: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); Incidence of dose limiting toxicity (DLT) events
Time frame: within 5 weeks
Phase I: Determine the Maximum Tolerated Dose (MTD) and/or the Recommended Phase II Dose (RP2D)
Time frame: within 5 weeks
Phase IIa： The percentage of cervical lesions that have regressed to CIN1 or normal as confirmed by virology and histopathology
Time frame: within 52 weeks
3 secondary outcomes
Phase I: The percentage of cervical lesions that have regressed to CIN1 or normal, as confirmed by virology and histopathology studies
Time frame: within 52 weeks
Phase I&Phase IIa: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: within 52 weeks
Phase I&Phase IIa: Percentage of HPV and E6E7 mRNA elimination
Time frame: within 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BBM-C101 in people with High-grade Squamous Intraepithelial Lesions of the Cervix Associated With Human Papillomavirus (HPV) Type 16 and/or HPV Type 18 Infection, run by Shanghai Mianyi Biopharmaceutical Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Wu, PhD (15721557980, wu-xia@beliefbiomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); Incidence of dose limiting toxicity (DLT) events (time frame: within 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.