protocolSection identificationModule nctId: NCT06273553, orgStudyIdInfo id: RG002-A1201, briefTitle: A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-10, completionDateStruct date: 2027-12, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: RinuaGene Biotechnology Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3)., conditionsModule conditions: Human Papillomavirus Associated Intraepithelial Neoplasia, conditions: Cervical Intraepithelial Neoplasia Grade 2/3, conditions: Human Papillomavirus Type 16 Infection, conditions: Human Papillomavirus Type 18 Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 39, type: ESTIMATED, armsInterventionsModule interventions name: RG002 injection, outcomesModule primaryOutcomes measure: Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events, primaryOutcomes measure: Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection, primaryOutcomes measure: Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression, secondaryOutcomes measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression, secondaryOutcomes measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with clearance of HPV16/18, secondaryOutcomes measure: Part A: Preliminary efficacy of RG002 Injection,measured by proportion of subjects with histopathological regression and clearance of HPV16/18, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the level of cellular immune response, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the proportion of T lymphocytes, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the expression of cytokines in serum, secondaryOutcomes measure: Part A and B: Immunogenicity of RG002 Injection,measured by the serum levels of anti-HPV16 and anti-HPV18 IgG antibodies., secondaryOutcomes measure: Part A and B: Exposure level of RG002 Injection, measured by mRNA, secondaryOutcomes measure: Part A and B: Exposure level of RG002 Injection, measured by cationic lipids, secondaryOutcomes measure: Part A and B: Anti-drug antibody (ADA) to polyethylene glycol (PEG) of RG002 injection, measured by the serum titer of anti-PEG IgG and anti-PEG IgM, secondaryOutcomes measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression, secondaryOutcomes measure: Part B: Secondary efficacy, measured by proportion of subjects with clearance of HPV16/18, secondaryOutcomes measure: Part B: Secondary efficacy, measured by proportion of subjects with histopathological regression and clearance of HPV16/18, secondaryOutcomes measure: Part B: Safety and tolerability of RG002 Injection, measured by the incidence of adverse events, secondaryOutcomes measure: Part B: Optionally assess the biomarker of RG002 Injection, measured by the level of potential biomarkers and the level of infiltrating T cells and myeloid cells in the lesions., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, hasResults: False