HPV16 and/or HPV18 associated CIN2/3
Conditions
Interventions
Experimental group:All study participants will receive RG002 injections at the indicated dose levels as intramuscular injections once every 2 weeks (D1, D15 and D29) for a total of 3 treatments. After
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent according to study center guidelines. 2. Females aged 18~50 years old (including boundary values). 3. Body mass index (BMI) =15% of the cervical area and =1.5×10^9/L, hemoglobin (HGB) >=90 g/L, platelets >=100×10^9/ L; Renal function: creatinine <=1.5× upper limit of normal range (ULN) or creatinine clearance <60 ml/min; Liver function: total bilirubin <=1.5×ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=1.5×ULN. 9. Women of childbearing potential (WOCBP) who have not had unprotected sex for 14 days prior to enrollment and have used an effective method of contraception up to 9 months after the last injection. 10. Able and willing to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Previous history of adenocarcinoma in situ (AIS) of the cervix, or evidence of atypical endometrial or glandular cell or invasive cervical cancer found on cervical biopsy within 12 weeks prior to the first study dose; 2. Previous history of high-grade intraepithelial neoplasia or invasive carcinoma of the vulva, vagina or anus; 3. History of severe allergy to any vaccine or severe hypersensitivity reaction to a known component of RG002 injection as judged by the investigator; 4. Positive serological test result for human immunodeficiency virus (HIV) or syphilis infection at screening; or positive for hepatitis B virus surface antigen (HBsAg) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) copy number >=500 IU/ml (or 2500 copy number, or the lower limit of positive test value in the research center) at screening; or the research center is positive for hepatitis C antibody (HCV-Ab) and hepatitis C virus (HCV) ribonucleic acid (RNA) with >=ULN; Active herpes simplex virus (HSV) infection; 5. Subjects with moderate to severe fatty liver comorbidities at screening; 6. Subjects with poorly controlled diabetes mellitus (fasting blood glucose >=10 mmol/L) at screening; 7. Have a history of severe cardiovascular and cerebrovascular diseases, including but not limited to severe cardiac rhythm or conduction abnormalities, ventricular arrhythmias requiring clinical intervention; Repeat 12-lead ECG showing QTcF interval >=470 ms; Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other >=3 grade cardiovascular and cerebrovascular events within 6 months prior to the first dose; New York College of Cardiology (NYHA) cardiac function grade >=Class III or clinically poorly controlled hypertension (systolic blood pressure >=150 mmHg, diastolic blood pressure >=100 mmHg); 8. Major surgery (other than surgery for diagnostic purposes) within 4 weeks prior to the first dose, or anticipated major surgery (other than surgery for diagnostic purposes) during the study; If major surgery has been performed > 4 weeks prior to the first dose of study drug, individual subjects must have recovered adequately from toxicity and/or complications of intervention treatment prior to the first dose of study drug; 9. Have hereditary bleeding tendencies or coagulation disorders, or have a history of thrombosis or hemorrhage, or need to continue to use anticoagulants; 10. Pregnant or lactating female subjects, or positive serum human chorionic gonadotropin (HCG) test result at screening (Visit V1); 11. Currently receiving, or have been treated with systemic steroids at the following doses prior to the first study dose; Long-term corticosteroids: >=0.5 mg/kg/day oral prednisolone or equivalent within 30 days prior to the first study dose, Occasional corticosteroids: >=1 mg/kg/day of oral prednisolone or equivalent within 30 days prior to the first study dose, >=2 shorter courses (> per course). 3 days), Note: Current or recent topical use (including eye drops, or inhaled corticosteroids, or dermatologic medications) is acceptable. 12. History of autoimmune disease or immunosuppression due to treatment of concurrent conditions: HIV therapy, anti-rheumatic drugs, organ or bone marrow transplantation, or related treatments. 13. Previous history of malignant tumor or treatment; 14. Use of any blood products within 3 months prior to enrollment; 15. Any vaccine administered within 4 weeks prior to enrollment; 16. Have a history of any therapeut
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Types, incidence, severity, severity, and relevance to study drugs of adverse events;Clinically significant changes in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG).;MTD and/or RP2D of RG002 injection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness endpoints;Immunogenicity endpoints;Pharmacokinetic endpoints;PEG-ADA endpoint; | — |
Countries
China
Contacts
Public ContactZhu Lan
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed