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BBM-C101 in Cervical High-Grade Squamous Intraepithelial Lesions
NCT07668960Phase 2
Key facts
- Status
- Not yet recruiting
- Start
- Jun 2026
- Primary completion
- Dec 2029
- Countries
- 1
- Sponsor
- Mianyi Bio
- Drugs
- BBM-C101
- Conditions
- cervical squamous intraepithelial lesion (SIL)
01
Overview
Phase 2, open-label, single-arm trial of BBM-C101 in cervical squamous intraepithelial lesion (SIL), sponsored by Mianyi Bio. Primary endpoints: Incidence of Adverse Events and Serious Adverse Events at 5 weeks, Incidence of dose limiting toxicity events at 5 weeks and 2 more. Planned start Jun 2026; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Arm of BBM-C101
Patients receive BBM-C101 hypodermic injection once a week for 4 weeks (Low, Middle, or High dose groups).
03
Who it enrols
Women with HPV16/18-associated cervical HSIL who are treatment-naive for HPV/HSIL, have satisfactory colposcopy, and adequate organ function. Excludes patients with invasive carcinoma, prior therapeutic HPV vaccines, active infections, or history of malignancy/autoimmune disease.
04
Endpoints
Primary
Incidence of Adverse Events and Serious Adverse Events
Incidence of dose limiting toxicity events
Maximum Tolerated Dose and/or Recommended Phase II Dose
Percentage of cervical lesions that have regressed to CIN1 or normal
Secondary
Incidence of Adverse Events and Serious Adverse Events
Percentage of HPV and E6E7 mRNA elimination
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